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Different Vitamin D Preparations & FGF23 in Humans

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sherri-Ann M. Burnett-Bowie, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00957879
First received: August 11, 2009
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

Fibroblast growth factor 23 (FGF23) is a new hormone which controls phosphate and vitamin D levels in humans. Excess FGF23 is associated with an increased risk of death in patients with chronic kidney disease. In this study the investigators are investigating the effects of different forms of vitamin D on FGF23 levels in the blood in order to increase our understanding of how this important hormone works.


Condition Intervention
Vitamin D Deficiency
Dietary Supplement: Ergocalciferol
Dietary Supplement: Calcitriol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effect of Different Vitamin D Preparations on Circulating FGF23 Levels in Vitamin D Deficient Caucasian and African-American Men and Women

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in FGF23 levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in serum phosphate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in urinary phosphate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in serum calcium [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: May 2009
Study Completion Date: March 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ergocalciferol
Weekly ergocalciferol for 12 weeks
Dietary Supplement: Ergocalciferol
Ergocalciferol 50000 international units by mouth weekly for 12 weeks
Active Comparator: calcitriol
Daily calcitriol for 12 weeks
Dietary Supplement: Calcitriol
Calcitriol 0.5 mcg by mouth daily for 12 weeks

Detailed Description:

Fibroblast growth factor 23 (FGF23) is a novel hormone involved in phosphate and vitamin D physiology. X-linked hypophosphatemia (XLH), autosomal dominant hypophosphatemic rickets (ADHR), and tumor induced osteomalacia (TIO) are 3 rare diseases characterized by rickets/osteomalacia, fractures, and hypophosphatemia secondary to renal phosphate wasting and inappropriately low levels of activated vitamin D (calcitriol), which are caused by excess amounts of or mutated FGF23. FGF23 excess also occurs in renal failure, where elevated FGF23 levels predict increased mortality. Thus, abnormal FGF23 appears to be central to both rare and common diseases. While FGF23 appears to be regulated by vitamin D, dietary and serum phosphate, much is still unknown. The effects of different forms of vitamin D on FGF23 stimulation are not well characterized. Similarly, any racial differences in the regulation of FGF23 by vitamin D have not been investigated.

To address these knowledge deficits, we will randomize 52 vitamin D deficient (25OHD < or = 24 ng/mL by LC/MS) Caucasian and African-American men and women to treatment with either dietary vitamin D or activated vitamin D for 12 weeks. Our primary endpoint will be the change in FGF23 with dietary versus activated vitamin D.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 to 45 yrs
  • Serum 25OHD < 24 ng/mL by liquid chromatography/mass spectroscopy
  • At least 1 menses in the last 3 months (females) and normal serum testosterone (males)
  • African-American or Caucasian race

Exclusion Criteria:

  • Significant cardiac, hepatic, oncologic, or psychiatric disease
  • History of malabsorption, kidney stones, or recent alcohol excess/abuse
  • Use of medications known to affect serum phosphate levels including phosphate-binding antacids, sodium etidronate, calcitonin, excessive doses of vitamin D (> 1000 units per day), excessive doses of vitamin A (> 20,000 units/day), calcitriol, growth hormone, or anti-convulsants
  • Use of thiazide diuretics or cholestyramine
  • Serum calcium < 8 or > 11 mg/dL, creatinine > 1.5 mg/dL, or Hgb < 11 gm/dL
  • Serum glucose >140mg/dL
  • Liver function tests > 2 times the upper limit of normal
  • TSH < 0.1 or > 7 uU/mL
  • WBC < 2,000 or > 15,000/cmm
  • Platelet count < 100,000 or > 500,000/cum
  • Hormone replacement therapy (however, oral contraceptives are allowed) or testosterone use
  • Urine beta-hCG positive (females)
  • Serum phosphate > 4.6 mg/dL
  • Allergy to vitamin D
  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: NCT00957879

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Sherri-Ann M Burnett-Bowie, MD, MPH Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Sherri-Ann M. Burnett-Bowie, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00957879     History of Changes
Other Study ID Numbers: 2009P000567, K23DK073356
Study First Received: August 11, 2009
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Vitamin D
FGF23
FGF-23
Phosphate

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcitriol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Calcium Channel Agonists
Cardiovascular Agents
Growth Substances
Membrane Transport Modulators
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 25, 2014