Clinical trial · Interventional
Vitamin D for the Treatment of Women With Polycystic Ovary Syndrome (PCOS)
Vitamin D Supplementation in Polycystic Ovary Syndrome: a Randomized Controlled Trial.
NCT00907153CI-TRIAL-00030850completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if vitamin D will improve insulin resistance, inflammation, and overall well-being in women with PCOS.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Vitamin D | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vitamin D
- interventionNames
- Dietary Supplement: Vitamin D
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI)
- timeFrame
- Baseline and 12 weeks
- description
- Quantitative insulin sensitivity check index (QUICKI) is a validated measure of insulin sensitivity based on fasting insulin and glucose. Quantitative insulin sensitivity check index (QUICKI) = 1/\[log(I(0)) + log(G(0))\]).
Secondary outcomes (15)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of PCOS based on: * Eight or fewer menstrual periods per year or spontaneous intermenstrual periods of greater than or equal to 45 days, and * Elevated testosterone levels Exclusion Criteria: * Current Pregnancy or Nursing * Elevated calcium * Kidney Stones or kidney disease * Current use of vitamin D (other than a multivitamin) * Use of metformin or other insulin sensitizing drugs in the last 3 months * Elevated prolactin or untreated thyroid disease * Diabetes, Liver disease, Heart disease, or other serious medical condition
References
Publications (1)
- RESULTRaja-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. PMID 24636395