N/A N=92 Randomized Triple-blind Treatment

Vitamin D Deficiency, Insulin Resistance and FGF-23

Vitamin D Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT00491322 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2018

Primary outcome: Primary: Fibroblast Growth Factor 23 (FGF23) After 12 Weeks of Weekly Ergocalciferol 50000 Units — 74; 39 pg/mL — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Ergocalciferol (Dietary_supplement); Ergocalciferol placebo (Dietary_supplement)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Feb 2008

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

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.

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)

View full record on ClinicalTrials.gov →

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.