The Effects of Dietary Phosphate Intake on Calciotropic Hormones and FGF23.

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00305279
First received: March 17, 2006
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Healthy
Kidney Failure, Chronic
Other: Dietary

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: The Effects of Dietary Phosphate Intake on Calciotropic Hormones and FGF23

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Hormonal regulators of mineral metabolism [ Time Frame: Last two days of each intervention phase ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Other: Dietary
Dietary
Active Comparator: 2 Other: Dietary
Dietary
Active Comparator: 3 Other: Dietary
Dietary

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305279

Locations
United States, California
University of California
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Diana M Antoniucci, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00305279     History of Changes
Other Study ID Numbers: H40550-27771, 1K23RR020343
Study First Received: March 17, 2006
Last Updated: October 9, 2013
Health Authority: United States: Institutional Review Board
United States: National Institutes of Health

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on September 16, 2014