Different Vitamin D Preparations & FGF23 in Humans
Completed · Not applicable
Conditions studied: Vitamin D Deficiency
In brief
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.
Key facts
- Study ID
- NCT00957879
- Run by
- Massachusetts General Hospital
- People needed
- 42
- Starts
- 2009-05-01
- Expected to finish
- 2011-03-01
- Last updated by the study team
- 2012-04-19
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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