## Protocol Section
### Identification Module
**NCT ID:** NCT01295879

**Brief Title:** Vitamin D Repletion in Stone Formers With Hypercalciuria

**Official Title:** Effect of Ergocalciferol Repletion on Urine Calcium Among Stone Formers With Vitamin D Deficiency and Hypercalciuria

#### Organization Study ID Info
**ID:** AAAF3346
#### Organization
**Class:** OTHER
**Full Name:** New York Presbyterian Hospital
### Status Module
#### Completion Date
**Date:** 2011-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-10-23

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-09-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-04

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2012-10-23

**Type:** ESTIMATED

**Results First Submit Date:** 2012-09-10

**Results First Submit QC Date:** 2012-09-10

#### Start Date
**Date:** 2010-09

**Status Verified Date:** 2012-09

#### Study First Post Date
**Date:** 2011-02-15
**Type:** ESTIMATED
**Study First Submit Date:** 2011-02-14
**Study First Submit QC Date:** 2011-02-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** New York Presbyterian Hospital

#### Responsible Party

**Investigator Affiliation:** New York Presbyterian Hospital

**Investigator Full Name:** David E. Leaf

**Investigator Title:** Nephrology Fellow

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Vitamin D plays a critical role in maintaining bone health, as well as preventing cardiovascular disease, cancer, and various autoimmune diseases, such as diabetes. Vitamin D deficiency is very common in the United States and worldwide, and is now being increasingly recognized and treated. One group in which vitamin D deficiency may be particularly important is patients who have had kidney stones. These patients frequently have elevated levels of calcium in their urine, which is a common and important risk factor for calcium containing kidney stones. Because vitamin D increases absorption of calcium into the blood by the intestines, physicians may be reluctant to prescribe vitamin D therapy to patients with vitamin D deficiency if they also have kidney stones and high amounts of calcium in the urine. They are concerned about the possible risk of increasing the amount of calcium in the urine (and thereby increasing the risk of calcium stones occurring again). However, studies in patients without kidney stones, as well as studies in patients with high calcium levels in the urine, have demonstrated that giving vitamin D is effective and safe and does not increase calcium in the urine. Therefore, the investigators will study the effects of giving vitamin D on the amount of calcium in the urine in patients with a history of kidney stones and elevated calcium in the urine. The investigators will evaluate the safety of giving vitamin D to this particular group of patients.

**Detailed Description:** The investigators plan to conduct a clinic-based interventional study of 30 patients followed at outpatient urology clinics associated with New York Presbyterian Hospital (NYPH). The intervention is supplementation with oral ergocalciferol 50,000 IU per week for 8 weeks, and each participant will serve as his/her own control. The formulation, dose, and duration of vitamin D therapy is reflective of that which is given in routine clinical practice to patients with vitamin D deficiency. The outcome is the change in urinary calcium excretion.

### Conditions Module

**Conditions:**

- Nephrolithiasis

- Urolithiasis

- Idiopathic Hypercalciuria

- Vitamin D Deficiency

- Disorder of Vitamin D

**Keywords:**

- Vitamin D insufficiency

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks

**Intervention Names:**

- Drug: Ergocalciferol

**Label:** Ergocalciferol

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Ergocalciferol

**Description:** Ergocalciferol 50,000 IU's orally per week, for 8 weeks

**Name:** Ergocalciferol

**Other Names:**

- Vitamin D2

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones

**Measure:** Change in 24 Hour Urine Calcium

**Time Frame:** 8 weeks

#### Secondary Outcomes

**Description:** Elevated values of calcium oxalate supersaturation in the urine are a risk factor for recurrence of calcium kidney stones

**Measure:** Change in 24 Hour Urine Supersaturation of Calcium Oxalate

**Time Frame:** 8 weeks

**Measure:** Recurrence of Kidney Stones

**Time Frame:** 8 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* History of nephrolithiasis as per medical record
* Urinary calcium excretion between 150 and 400 mg/day (measured within 3 months of study enrollment)
* 25(OH)D deficiency or insufficiency (defined as a serum level \< 30 ng/ml) within 3 months of enrollment

Exclusion Criteria:

* Pregnant women, since the optimal dose of vitamin D supplementation in this population has not been rigorously studied.
* Known uric acid, cystine, or struvite stone disease (because our intervention is predominantly aimed at patients with calcium stone disease). An exception to this is patients who have passed both uric acid and calcium stones, or patients who have passed stones of mixed composition (uric acid and calcium).
* Hypercalcemia (serum calcium \> 10.4 mg/dL) at baseline
* Acute stone event or gross hematuria (blood in the urine) within the past 2 months
* Recent stone intervention within the past 1 month
* Suspected or known secondary causes of hypercalciuria, such as primary hyperparathyroidism, sarcoidosis, hyperthyroidism, or malignancy (except nonmelanoma skin cancer)
* Addition or dose change of medicines potentially affecting urinary calcium since the baseline 24hour urine collection (including diuretics, magnesium supplements, potassium supplements, potassium citrate, and vitamin D supplementation)

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New York

**Country:** United States

**Facility:** New York Presbyterian Hospital

**State:** New York

**Zip:** 10032

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001361

- Term: Avitaminosis

- ID: D000003677

- Term: Deficiency Diseases

- ID: D000044342

- Term: Malnutrition

- ID: D000009748

- Term: Nutrition Disorders

- 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: D000052801

- Term: Male Urogenital Diseases

- ID: D000014545

- Term: Urinary Calculi

- ID: D000002137

- Term: Calculi

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000007674

- Term: Kidney Diseases

- ID: D000020924

- Term: Urological Manifestations

### 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

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M10693

- Name: Kidney Calculi

- Relevance: HIGH

- As Found: Nephrolithiasis

- ID: M27103

- Name: Urolithiasis

- Relevance: HIGH

- As Found: Urolithiasis

- 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: Nephrolithiasis

- ID: M17551

- Name: Vitamin D Deficiency

- Relevance: HIGH

- As Found: Vitamin D Deficiency

- ID: M27341

- Name: Hypercalciuria

- Relevance: HIGH

- As Found: Hypercalciuria

- ID: M4660

- Name: Avitaminosis

- Relevance: LOW

- As Found: Unknown

- ID: M6879

- Name: Deficiency Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25306

- Name: Malnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- 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

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22659

- Name: Urological Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000052878

- Term: Urolithiasis

- ID: D000053040

- Term: Nephrolithiasis

- ID: D000007669

- Term: Kidney Calculi

- ID: D000014808

- Term: Vitamin D Deficiency

- ID: D000053565

- Term: Hypercalciuria

### Intervention Browse Module - Ancestors

- ID: D000014815

- Term: Vitamins

- ID: D000018977

- Term: Micronutrients

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000050071

- Term: Bone Density Conservation Agents

- ID: D000077264

- Term: Calcium-Regulating Hormones and Agents

### Intervention Browse Module - Browse Branches

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M17550

- Name: Vitamin D

- Relevance: HIGH

- As Found: Anti-tumor

- ID: M6003

- Name: Cholecalciferol

- Relevance: LOW

- As Found: Unknown

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: M8026

- Name: Ergocalciferols

- Relevance: HIGH

- As Found: Anti-tumor

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: T442

- Name: Cholecalciferol

- Relevance: LOW

- As Found: Unknown

- ID: T479

- Name: Vitamin D3

- Relevance: LOW

- As Found: Unknown

- ID: T440

- Name: Calciferol

- Relevance: HIGH

- As Found: Anti-tumor

- ID: T445

- Name: Ergocalciferol

- Relevance: HIGH

- As Found: Anti-tumor

- ID: T478

- Name: Vitamin D2

- Relevance: HIGH

- As Found: Interferon alfa-2a

### Intervention Browse Module - Meshes

- ID: D000014807

- Term: Vitamin D

- ID: D000004872

- Term: Ergocalciferols

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Ergocalciferol

**Description:** Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks

**ID:** EG000

**Other Num at Risk:** 29

**Serious Number At Risk:** 29

**Title:** Ergocalciferol

**Frequency Threshold:** 0

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 29

**Units:** Participants

### Group

**ID:** BG000

**Title:** Ergocalciferol

**Description:** Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 27

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 2

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 12

**Value:** 48

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 7

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 22

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 29

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** DELEAF@partners.org
**Organization:** Brigham and Women's Hospital
**Phone:** 617-732-5951
**Title:** David E. Leaf, M.D., Renal Fellow
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 71
- **Upper Limit:** 
- **Value:** 2
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.5
- **Upper Limit:** 
- **Value:** -1
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 8 weeks
**Title:** Change in 24 Hour Urine Calcium
**Type:** PRIMARY
**Unit of Measure:** mg/day
##### Group
**Description:** Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
**ID:** OG000
**Title:** Ergocalciferol
#### Outcome Measure 2
**Description:** Elevated values of calcium oxalate supersaturation in the urine are a risk factor for recurrence of calcium kidney stones
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 8 weeks
**Title:** Change in 24 Hour Urine Supersaturation of Calcium Oxalate
**Type:** SECONDARY
**Unit of Measure:** (unitless)
##### Group
**Description:** Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
**ID:** OG000
**Title:** Ergocalciferol
#### Outcome Measure 3
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 8 weeks
**Title:** Recurrence of Kidney Stones
**Type:** SECONDARY
**Unit of Measure:** # of stone recurrences
##### Group
**Description:** Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
**ID:** OG000
**Title:** Ergocalciferol
### Participant Flow Module
#### Group
**Description:** Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
**ID:** FG000
**Title:** Ergocalciferol
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 29
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 29
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Has Results:** True