Clinical trial · Observational
Vitamin D Status in Relation to Insulin Sensitivity Among Saudi Women With Polycystic Ovary Syndrome
Vitamin D Status in Relation to Insulin Sensitivity, Resistance and Inflammatory Response Among Saudi Women With Polycystic Ovary Syndrome
NCT02164552CI-TRIAL-00014846CEOR-04-08unknownClinicalTrials.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 study tests the hypothesis that correction of vitamin D deficiency among women with PCOS will improve insulin sensitivity and resistance and inflammatory response to 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 pills | Other | — | UNRESOLVED |
| Vitamin D3 pills | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Vitamin D3 pills
- description
- Vitamin D3 (cholecalciferol) supplementation (50,000 IU/week for 8 weeks) followed by 1000 IU/day for 16 weeks
- interventionNames
- Dietary Supplement: Vitamin D3 pills
- label
- Placebo pill
- description
- Placebo pills will be given 1 per week for 8 weeks followed by 1 per day for 16 weeks
- interventionNames
- Other: Placebo pills
Primary outcomes (1)
- measure
- Correction of vitamin D deficiency improves insulin resistance compared to placebo
- timeFrame
- 24 weeks
- description
- The primary endpoint was an improvement in insulin resistance parameters \[Fasting serum insulin,glucose-to-insulin ratio (GIR) and homeostasis model assessment (HOMA) \] from baseline and at 24 weeks in vitamin D supplemented as compared with placebo groups.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: PCOS diagnosis to include three of the Rotterdam criteria Exclusion Criteria: pregnancy lactation taking vitamin d or calcium supplement in excess of a regular multivitamins diabetes mellitus uncontrolled hypertension liver disease renal disease secondary causes of hyperandrogenism metabolic bone disease thyroid dysfunction taking oral contraceptives taking hypoglycemic agents (metformin or thiazolidinediones) medication to affect plasma sex steroids for \>/3 months before the study smokers
References
Publications (0)
Data not yet available
No reference posted for this study.