## Protocol Section
### Identification Module
**NCT ID:** NCT01754779

**Brief Title:** Treatment for Calcium Phosphate Kidney Stone Disease

**Official Title:** Pharmacological Therapy for Calcium Phosphate Urolithiasis

#### Organization Study ID Info
**ID:** 032012-058
#### Organization
**Class:** OTHER
**Full Name:** University of Texas Southwestern Medical Center
#### Secondary ID Infos
**ID:** R21DK097476-01
**Link:** https://reporter.nih.gov/quickSearch/R21DK097476-01
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2023-02-16

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-04

**Type:** ACTUAL

**Last Update Submit Date:** 2024-03-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-02-16

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2024-04-04

**Type:** ACTUAL

**Results First Submit Date:** 2024-01-23

**Results First Submit QC Date:** 2024-03-07

#### Start Date
**Date:** 2012-07

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2012-12-21
**Type:** ESTIMATED
**Study First Submit Date:** 2012-12-14
**Study First Submit QC Date:** 2012-12-18
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Texas Southwestern Medical Center

#### Responsible Party

**Investigator Affiliation:** University of Texas Southwestern Medical Center

**Investigator Full Name:** Naim Maalouf

**Investigator Title:** Associate Professor of Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The investigators will examine in two studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of Calcium Phosphate stone formers.

**Detailed Description:** We will examine in two short-term placebo-controlled cross-over metabolic studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of CaP stone formers.

The first study will be conducted in hypocitraturic CaP stone formers without hypercalciuria, and will compare the effects of potassium citrate, citric acid and placebo.

The second study will be conducted in hypercalciuric CaP stone formers on a thiazide diuretic who require potassium supplementation, and will compare the effects of potassium chloride alone, potassium chloride + citric acid, and potassium citrate alone. Physicochemical assays will be applied in addition to computer-based stone risk prediction programs to assess risk of stone recurrence.

### Conditions Module

**Conditions:**

- Calcium Phosphate Kidney Stones

**Keywords:**

- calcium phosphate

- urolithiasis

- kidney stones

- hypercalciuria

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 13

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week)

**Intervention Names:**

- Dietary Supplement: Placebo

- Dietary Supplement: Citric Acid

- Dietary Supplement: Potassium Citrate

**Label:** Placebo, then Citric Acid, then Potassium Citrate

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week)

**Intervention Names:**

- Dietary Supplement: Placebo

- Dietary Supplement: Citric Acid

- Dietary Supplement: Potassium Citrate

**Label:** Placebo, then Potassium Citrate, then Citric Acid

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week)

**Intervention Names:**

- Dietary Supplement: Placebo

- Dietary Supplement: Citric Acid

- Dietary Supplement: Potassium Citrate

**Label:** Potassium Citrate, then Placebo, then Citric Acid

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week)

**Intervention Names:**

- Dietary Supplement: Placebo

- Dietary Supplement: Citric Acid

- Dietary Supplement: Potassium Citrate

**Label:** Potassium Citrate, then Citric Acid, then Placebo

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week)

**Intervention Names:**

- Dietary Supplement: Placebo

- Dietary Supplement: Citric Acid

- Dietary Supplement: Potassium Citrate

**Label:** Citric Acid, then Potassium Citrate, then Placebo

**Type:** EXPERIMENTAL

#### Arm Group 6

**Description:** Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week)

**Intervention Names:**

- Dietary Supplement: Placebo

- Dietary Supplement: Citric Acid

- Dietary Supplement: Potassium Citrate

**Label:** Citric Acid, then Placebo, then Potassium Citrate

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Citric Acid, then Placebo, then Potassium Citrate

- Citric Acid, then Potassium Citrate, then Placebo

- Placebo, then Citric Acid, then Potassium Citrate

- Placebo, then Potassium Citrate, then Citric Acid

- Potassium Citrate, then Citric Acid, then Placebo

- Potassium Citrate, then Placebo, then Citric Acid

**Description:** 3 tablets twice daily of matching placebo during the placebo phase.

**Name:** Placebo

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Citric Acid, then Placebo, then Potassium Citrate

- Citric Acid, then Potassium Citrate, then Placebo

- Placebo, then Citric Acid, then Potassium Citrate

- Placebo, then Potassium Citrate, then Citric Acid

- Potassium Citrate, then Citric Acid, then Placebo

- Potassium Citrate, then Placebo, then Citric Acid

**Description:** 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)

**Name:** Citric Acid

**Type:** DIETARY_SUPPLEMENT

#### Intervention 3

**Arm Group Labels:**

- Citric Acid, then Placebo, then Potassium Citrate

- Citric Acid, then Potassium Citrate, then Placebo

- Placebo, then Citric Acid, then Potassium Citrate

- Placebo, then Potassium Citrate, then Citric Acid

- Potassium Citrate, then Citric Acid, then Placebo

- Potassium Citrate, then Placebo, then Citric Acid

**Description:** 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)

**Name:** Potassium Citrate

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** This variable represents a ratio of the calcium phosphate saturation in a given urine sample to the calcium phosphate saturation at the point of precipitation and hence this measure has no units.

**Measure:** Urinary Calcium Phosphate Saturation

**Time Frame:** 2 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Aim 1

* Hypocitraturic CaP stone formers
* urine citrate \<320mg/d
* elevated pH as 24-hr urine pH above 6.40
* \>21 years

Aim 2

* Hypercalciuric CaP stone formers
* 24hr urine calcium \>250mg/d in women and \>300mg/d in men prior to indapamide use
* high pH as \>6.40 in the absence of urinary tract infection
* \>21 years

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Dallas

**Country:** United States

**Facility:** UT Southwestern Medical Center

**State:** Texas

**Zip:** 75390-8885

#### Overall Officials

**Official 1:**

**Affiliation:** UT Southwestern Medical Center

**Name:** Naim M Maalouf, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Doizi S, Poindexter JR, Pearle MS, Blanco F, Moe OW, Sakhaee K, Maalouf NM. Impact of Potassium Citrate vs Citric Acid on Urinary Stone Risk in Calcium Phosphate Stone Formers. J Urol. 2018 Dec;200(6):1278-1284. doi: 10.1016/j.juro.2018.07.039. Epub 2018 Jul 20.

**PMID:** 30036516

## Document Section

### Large Document Module

#### Large Docs

- Date: 2018-02-21

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 378271

- Type Abbrev: Prot_SAP

- Upload Date: 2024-01-22T18:04

- Date: 2018-04-23

- Filename: ICF_001.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 171715

- Type Abbrev: ICF

- Upload Date: 2024-01-22T18:08

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002137

- Term: Calculi

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052878

- Term: Urolithiasis

- ID: D000014545

- Term: Urinary Calculi

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10693

- Name: Kidney Calculi

- Relevance: HIGH

- As Found: Kidney Stone

- ID: M27103

- Name: Urolithiasis

- Relevance: LOW

- As Found: Unknown

- ID: M17295

- Name: Urinary Calculi

- Relevance: LOW

- As Found: Unknown

- ID: M5399

- Name: Calculi

- Relevance: LOW

- As Found: Unknown

- ID: M27126

- Name: Nephrolithiasis

- Relevance: HIGH

- As Found: Kidney Stone

- ID: M27341

- Name: Hypercalciuria

- Relevance: LOW

- As Found: Unknown

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007669

- Term: Kidney Calculi

- ID: D000053040

- Term: Nephrolithiasis

### Intervention Browse Module - Ancestors

- ID: D000000925

- Term: Anticoagulants

- ID: D000065096

- Term: Calcium Chelating Agents

- ID: D000002614

- Term: Chelating Agents

- ID: D000064449

- Term: Sequestering Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000004232

- Term: Diuretics

- ID: D000045283

- Term: Natriuretic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000005100

- Term: Expectorants

- ID: D000019141

- Term: Respiratory System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnCoag

- Name: Anticoagulants

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: NaAg

- Name: Natriuretic Agents

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M21320

- Name: Citric Acid

- Relevance: HIGH

- As Found: Intravenous fluid

- ID: M1837

- Name: Sodium Citrate

- Relevance: HIGH

- As Found: Intravenous fluid

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: M21334

- Name: Potassium Citrate

- Relevance: HIGH

- As Found: Calcification

- ID: M4244

- Name: Anticoagulants

- Relevance: LOW

- As Found: Unknown

- ID: M5860

- Name: Chelating Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7411

- Name: Diuretics

- Relevance: LOW

- As Found: Unknown

- ID: M8243

- Name: Expectorants

- Relevance: LOW

- As Found: Unknown

- ID: M21137

- Name: Respiratory System Agents

- Relevance: LOW

- As Found: Unknown

- ID: T382

- Name: Citrate

- Relevance: HIGH

- As Found: Free

### Intervention Browse Module - Meshes

- ID: D000019357

- Term: Potassium Citrate

- ID: D000019343

- Term: Citric Acid

- ID: D000077559

- Term: Sodium Citrate

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Placebo

**Deaths Num At Risk:** 13

**Description:** Placebo tablets twice daily

Placebo: Matching placebo for both aims.

**ID:** EG000

**Other Num at Risk:** 13

**Serious Number At Risk:** 13

**Title:** Placebo

**Group ID:** EG001

**Title:** Citric Acid

**Deaths Num At Risk:** 13

**Description:** Citric acid tablets twice daily

Citric Acid

**ID:** EG001

**Other Num at Risk:** 13

**Serious Number At Risk:** 13

**Title:** Citric Acid

**Group ID:** EG002

**Title:** Potassium Citrate

**Deaths Num At Risk:** 13

**Description:** Potassium Citrate tablets twice daily

Potassium Citrate

**ID:** EG002

**Other Num at Risk:** 13

**Serious Number At Risk:** 13

**Title:** Potassium Citrate

**Frequency Threshold:** 0

**Time Frame:** 5 weeks

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 2

**Group ID:** BG001

**Value:** 1

**Group ID:** BG002

**Value:** 2

**Group ID:** BG003

**Value:** 3

**Group ID:** BG004

**Value:** 3

**Group ID:** BG005

**Value:** 2

**Group ID:** BG006

**Value:** 13

**Units:** Participants

### Group

**ID:** BG000

**Title:** Placebo, Then Citric Acid, Then Potassium Citrate

**Description:** Placebo: 3 tablets twice daily of matching placebo during the placebo phase.

Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)

Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)

### Group

**ID:** BG001

**Title:** Placebo, Then Potassium Citrate, Then Citric Acid

**Description:** Placebo: 3 tablets twice daily of matching placebo during the placebo phase.

Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)

Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)

### Group

**ID:** BG002

**Title:** Potassium Citrate, Then Placebo, Then Citric Acid

**Description:** Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)

Placebo: 3 tablets twice daily of matching placebo during the placebo phase.

Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)

### Group

**ID:** BG003

**Title:** Potassium Citrate, Then Citric Acid, Then Placebo

**Description:** Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)

Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)

Placebo: 3 tablets twice daily of matching placebo during the placebo phase.

### Group

**ID:** BG004

**Title:** Citric Acid, Then Potassium Citrate, Then Placebo

**Description:** Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)

Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)

Placebo: 3 tablets twice daily of matching placebo during the placebo phase.

### Group

**ID:** BG005

**Title:** Citric Acid, Then Placebo, Then Potassium Citrate

**Description:** Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)

Placebo: 3 tablets twice daily of matching placebo during the placebo phase.

Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)

### Group

**ID:** BG006

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.2

**Value:** 35.9

#### Measurement

**Group ID:** BG001

**Value:** 34.8

#### Measurement

**Group ID:** BG002

**Spread:** 27.9

**Value:** 49.2

#### Measurement

**Group ID:** BG003

**Spread:** 24.5

**Value:** 41.4

#### Measurement

**Group ID:** BG004

**Spread:** 11.8

**Value:** 45.6

#### Measurement

**Group ID:** BG005

**Spread:** 1.3

**Value:** 35.6

#### Measurement

**Group ID:** BG006

**Spread:** 15

**Value:** 41

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 2

#### Measurement

**Group ID:** BG004

**Value:** 3

#### Measurement

**Group ID:** BG005

**Value:** 2

#### Measurement

**Group ID:** BG006

**Value:** 11

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 1

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 2

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 2

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 2

**Class Title:** Black

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 3

#### Measurement

**Group ID:** BG004

**Value:** 1

#### Measurement

**Group ID:** BG005

**Value:** 2

#### Measurement

**Group ID:** BG006

**Value:** 11

**Class Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 1

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 4

**Class Title:** Hispanic

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 2

#### Measurement

**Group ID:** BG004

**Value:** 3

#### Measurement

**Group ID:** BG005

**Value:** 2

#### Measurement

**Group ID:** BG006

**Value:** 8

**Class Title:** Non-Hispanic

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 0.13

**Value:** 1.66

#### Measurement

**Group ID:** BG001

**Value:** 1.58

#### Measurement

**Group ID:** BG002

**Spread:** 0.02

**Value:** 1.56

#### Measurement

**Group ID:** BG003

**Spread:** 0.18

**Value:** 1.63

#### Measurement

**Group ID:** BG004

**Spread:** 0.06

**Value:** 1.69

#### Measurement

**Group ID:** BG005

**Spread:** 0.05

**Value:** 1.64

#### Measurement

**Group ID:** BG006

**Spread:** 0.10

**Value:** 1.63

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 3.4

**Value:** 74.2

#### Measurement

**Group ID:** BG001

**Value:** 89.0

#### Measurement

**Group ID:** BG002

**Spread:** 18.0

**Value:** 70.3

#### Measurement

**Group ID:** BG003

**Spread:** 16.0

**Value:** 56.7

#### Measurement

**Group ID:** BG004

**Spread:** 11.0

**Value:** 91.4

#### Measurement

**Group ID:** BG005

**Spread:** 7.4

**Value:** 53.8

#### Measurement

**Group ID:** BG006

**Spread:** 18.5

**Value:** 71.6

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 2.8

**Value:** 26.9

#### Measurement

**Group ID:** BG001

**Value:** 35.9

#### Measurement

**Group ID:** BG002

**Spread:** 8.0

**Value:** 28.9

#### Measurement

**Group ID:** BG003

**Spread:** 2.7

**Value:** 21.2

#### Measurement

**Group ID:** BG004

**Spread:** 2.1

**Value:** 32.1

#### Measurement

**Group ID:** BG005

**Spread:** 4.0

**Value:** 20.2

#### Measurement

**Group ID:** BG006

**Spread:** 6.4

**Value:** 26.7

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** participants
### Measure 4
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Height
**Unit of Measure:** metres
### Measure 5
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Weight
**Unit of Measure:** kg
### Measure 6
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Body mass index (BMI)
**Unit of Measure:** kg/m^2
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Limitations and Caveats
**Description:** The second study (in hypercalciuric Cap stone formers) was never conducted due to difficulties in recruitment and limited budget.
### Point of Contact
**Email:** naim.maalouf@utsouthwestern.edu
**Organization:** UT Southwestern Medical Center
**Phone:** 214/648-2954
**Title:** Dr. Naim Maalouf
## Results Section - Outcome Measures Module
### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.07
- **Upper Limit:** 
- **Value:** 2.38
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.75
- **Upper Limit:** 
- **Value:** 1.97
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.96
- **Upper Limit:** 
- **Value:** 2.19
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** This variable represents a ratio of the calcium phosphate saturation in a given urine sample to the calcium phosphate saturation at the point of precipitation and hence this measure has no units.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 2 weeks
**Title:** Urinary Calcium Phosphate Saturation
**Type:** PRIMARY
**Unit of Measure:** no units
##### Group
**Description:** Placebo tablets twice daily

Placebo: Matching placebo for both aims.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Citric acid tablets twice daily

Citric Acid
**ID:** OG001
**Title:** Citric Acid
##### Group
**Description:** Potassium Citrate tablets twice daily

Potassium Citrate
**ID:** OG002
**Title:** Potassium Citrate
### Participant Flow Module
#### Group
**Description:** Placebo: 3 tablets twice daily of matching placebo during the placebo phase.

Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)

Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
**ID:** FG000
**Title:** Placebo, Then Citric Acid, Then Potassium Citrate
#### Group
**Description:** Placebo: 3 tablets twice daily of matching placebo during the placebo phase.

Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)

Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
**ID:** FG001
**Title:** Placebo, Then Potassium Citrate, Then Citric Acid
#### Group
**Description:** Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)

Placebo: 3 tablets twice daily of matching placebo during the placebo phase.

Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
**ID:** FG002
**Title:** Potassium Citrate, Then Placebo, Then Citric Acid
#### Group
**Description:** Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)

Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)

Placebo: 3 tablets twice daily of matching placebo during the placebo phase.
**ID:** FG003
**Title:** Potassium Citrate, Then Citric Acid, Then Placebo
#### Group
**Description:** Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)

Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)

Placebo: 3 tablets twice daily of matching placebo during the placebo phase.
**ID:** FG004
**Title:** Citric Acid, Then Potassium Citrate, Then Placebo
#### Group
**Description:** Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)

Placebo: 3 tablets twice daily of matching placebo during the placebo phase.

Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
**ID:** FG005
**Title:** Citric Acid, Then Placebo, Then Potassium Citrate
#### Period
**Title:** First Intervention (1 Week)
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 2
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 2
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
#### Period
**Title:** Washout (1 Week)
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 2
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 2
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
#### Period
**Title:** Second Intervention (1 Week)
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 2
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 2
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
#### Period
**Title:** Washout (1 Week)
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 2
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 2
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
#### Period
**Title:** Third Intervention (1 Week)
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 2
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 2
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
**Pre-Assignment Details:** Out of 41 patients who met inclusion criteria and were contacted for study enrollment, a total of 13 subjects agreed to enroll and were consented and each participant was evaluated during 3 phases in randomized order.
**Has Results:** True