Vitamin D Deficiency, Insulin Resistance and FGF-23
Completed · Not applicable · Has a placebo group
Conditions studied: Vitamin D Deficiency
In brief
The purpose of this project is to determine if treating vitamin D deficiency decreases insulin resistance and improves insulin secretion in healthy volunteers. Additionally, this project will investigate if treating vitamin D deficiency affects a new phosphate-regulating hormone called FGF-23.
Key facts
- Study ID
- NCT00491322
- Run by
- Massachusetts General Hospital
- People needed
- 92
- Starts
- 2006-05-01
- Expected to finish
- 2008-02-01
- Last updated by the study team
- 2018-05-02
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 25-OHD < or = 20 ng/mL
- At least 1 menses in the last 3 months (females) and normal serum testosterone (males)
You may not qualify if…
- Significant cardiac, hepatic, oncologic, or psychiatric disease
- History of diabetes mellitus, malabsorption, kidney stones, or recent alcohol excess/abuse (15 drinks per week in the last month)
- Fasting glucose > 126 mg/dl or 2 hour OGTT > 200 mg/dl
- 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 metformin or insulin sensitizing agents
- Serum calcium < 8 or > 11 mg/dL, creatinine > 1.5 mg/dL, or Hgb < 11 gm/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 or testosterone use
- Urine uhCG positive (females), testosterone < 270 ng/dL (males)
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.