N/A
Completed N=92
Vitamin D Deficiency, Insulin Resistance and FGF-23
Source: ClinicalTrials.gov NCT00491322 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
May 2018
Primary outcomePrimary: Fibroblast Growth Factor 23 (FGF23) After 12 Weeks of Weekly Ergocalciferol 50000 Units — 74; 39 pg/mL — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fibroblast Growth Factor 23 (FGF23) After 12 Weeks of Weekly Ergocalciferol 50000 Units |
74; 39 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Age 18 to 45 yrs
- Serum 25-OHD 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 11 mg/dL, creatinine > 1.5 mg/dL, or Hgb 2 times the upper limit of normal
- TSH 7 uU/mL
- WBC 15,000/cmm
- Platelet count 500,000/cum
- Hormone replacement therapy or testosterone use
- Urine uhCG positive (females), testosterone < 270 ng/dL (males)
Data sourced from ClinicalTrials.gov (NCT00491322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.