drugset

drugset / Trial / NCT00907153

Vitamin D for the Treatment of Women With Polycystic Ovary Syndrome (PCOS)

NCT00907153 ↗

Phase 1/2 Completed 36 enrolled Milton S. Hershey Medical Center

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine if vitamin D will improve insulin resistance, inflammation, and overall well-being in women with PCOS.

Timeline

Start: 2009-05
Primary completion: 2014-02
Completion: 2014-09

Outcome

Missed primary endpoint

registry Vitamin D vs Placebo; p = 0.05; Mean Difference (Net) -0.017 (95% CI -0.034 to -0.000) NCT00907153 ↗

paper There were no significant differences in quantitative insulin sensitivity check index and other measures of insulin sensitivity PMID 24636395 ↗

Publications

Results Raja-Khan N, Shah J, Stetter CM, Lott ME, Kunselman AR, Dodson WC, Legro RS. High-dose vitamin D supplementation and measures of insulin sensitivity in polycystic ovary syndrome: a randomized, controlled pilot trial. Fertil Steril. 2014 Jun;101(6):1740-6. doi: 10.1016/j.fertnstert.2014.02.021. Epub 2014 Mar 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vitamin D	Other / unclassified	300 ug	Oral

Indications