Vitamin D Deficiency, Insulin Resistance and FGF-23 (NCT00491322) | Clinical Trial Compass
CompletedNot Applicable
Vitamin D Deficiency, Insulin Resistance and FGF-23
United States92 participantsStarted 2006-05
Plain-language summary
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.
Who can participate
Age range18 Years ā 45 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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)
What they're measuring
1
Fibroblast Growth Factor 23 (FGF23) After 12 Weeks of Weekly Ergocalciferol 50000 Units