## Protocol Section
### Identification Module
**NCT ID:** NCT00305279

**Brief Title:** The Effects of Dietary Phosphate Intake on Calciotropic Hormones and FGF23.

**Official Title:** The Effects of Dietary Phosphate Intake on Calciotropic Hormones and FGF23

#### Organization Study ID Info
**ID:** H40550-27771
#### Organization
**Class:** OTHER
**Full Name:** University of California, San Francisco
#### Secondary ID Infos
**ID:** 1K23RR020343
**Link:** https://reporter.nih.gov/quickSearch/1K23RR020343
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2009-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-10-10

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-10-09

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2009-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2006-02

**Status Verified Date:** 2013-10

#### Study First Post Date
**Date:** 2006-03-21
**Type:** ESTIMATED
**Study First Submit Date:** 2006-03-17
**Study First Submit QC Date:** 2006-03-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institutes of Health (NIH)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of California, San Francisco

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** The purpose of this study is to determine the effects of different amounts of phosphorus in the diet on hormones that control phosphorus and bone health both in people who are healthy and in ones who have moderate kidney disease.

**Detailed Description:** Chronic kidney disease affects 11% of the US population; over half of those affected have skeletal manifestations of their renal disease. Renal osteodystrophy is a complex disease, in which multiple mineral systems and related hormones play a role, including phosphate homeostasis. Phosphate regulation primarily depends on renal handling of phosphate, which is partly controlled by parathyroid hormone and vitamin D. However, other mediators in this system clearly exist. Recently, evidence has been accruing that one such factor may be FGF23, a protein produced by osteogenic cells. States of excess FGF23 are associated with marked phosphate wasting, hypophosphatemia, osteomalacia, and inappropriately low calcitriol. FGF23 levels are measurable in healthy humans and markedly elevated in patients who require hemodialysis, although its physiologic role in either state is unknown. Some retrospective evidence suggests that FGF23 is affected by phosphate intake. We are performing a study to gather data describing the response of FGF23 to changes in dietary phosphorus intake in healthy men and women and in men and women with moderate renal insufficiency. The specific aims of this pilot study are: 1) To examine the physiologic effects of alterations in dietary phosphorus on FGF23 in healthy subjects; 2) To examine the physiologic response of FGF23 to dietary phosphorus alterations in patients with moderate renal failure; and 3) To assess whether serum levels of 1,25-dihydroxyvitamin D vary inversely with those of FGF23 when dietary phosphate is changed. The proposed research plan is a dietary intervention trial in which we will study the response of serum FGF23 levels to diets with varying phosphorus contents in healthy adults and adults with moderate renal insufficiency.

### Conditions Module

**Conditions:**

- Healthy

- Kidney Failure, Chronic

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Dietary

**Label:** 1

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Other: Dietary

**Label:** 2

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Intervention Names:**

- Other: Dietary

**Label:** 3

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** Dietary

**Name:** Dietary

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- 2

**Description:** Dietary

**Name:** Dietary

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- 3

**Description:** Dietary

**Name:** Dietary

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Hormonal regulators of mineral metabolism

**Time Frame:** Last two days of each intervention phase

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

HEALTHY SUBJECTS:

* Men 21-65 years of age;
* Premenopausal women over 21 years of age taking oral contraceptives;
* Postmenopausal women less than 65 years of age;

CHRONIC KIDNEY DISEASE SUBJECTS:

* Men 21-65 years of age;
* Premenopausal women over 21 years of age taking oral contraceptives;
* Postmenopausal women less than 65 years of age;
* Creatinine clearance between 30 and 59 ml/min/1.73 m2 as calculated using the equation derived from the Modification of Diet in Renal Disease (MDRD) study.

Exclusion Criteria:

* Medications affecting bone metabolism;
* Abnormal liver or GI function;
* Extreme electrolyte abnormalities;
* BMI \>30 kg/m2.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** San Francisco

**Country:** United States

**Facility:** University of California

**State:** California

**Zip:** 94143

#### Overall Officials

**Official 1:**

**Affiliation:** University of California, San Francisco

**Name:** Diana M Antoniucci, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- 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: D000052801

- Term: Male Urogenital Diseases

- ID: D000051436

- Term: Renal Insufficiency, Chronic

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### 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: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10699

- Name: Kidney Failure, Chronic

- Relevance: HIGH

- As Found: Kidney Failure, Chronic

- ID: M26718

- Name: Renal Insufficiency

- Relevance: HIGH

- As Found: Kidney Failure

- 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

- ID: M26717

- Name: Renal Insufficiency, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000051437

- Term: Renal Insufficiency

- ID: D000007676

- Term: Kidney Failure, Chronic

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M17550

- Name: Vitamin D

- Relevance: LOW

- As Found: Unknown

- ID: T440

- Name: Calciferol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
