Clinical trial · Interventional
Effect of Vitamin D Supplementation on Testosterone Level in Women With Polycystic Ovary Syndrome
Effect of Vitamin D Supplementation on Testosterone Level in Women With Polycystic Ovary Syndrome: A Randomized, Double-blind, Placebo-controlled Trial
NCT06101147CI-TRIAL-00079714completedPhase 2ClinicalTrials.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 goal of this randomized, double blind, placebo-controlled clinical trial is to learn about, the effect of low dose vitamin D supplementation compares with placebo-controlled group on testosterone level in women with polycystic ovary syndrome. Half of Participants will receive vitamin D and metformin while other half placebo and metformin.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PCOS | — | UNRESOLVED | — |
| Vitamin D | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo Oral Tablet | Drug | — | UNRESOLVED |
| Vitamin D3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vitamin D group
- interventionNames
- Drug: Vitamin D3
- type
- PLACEBO_COMPARATOR
- label
- Placebo group
- interventionNames
- Drug: Placebo Oral Tablet
Primary outcomes (1)
- measure
- Total Testosterone
- timeFrame
- 1 year
- description
- The estimated testosterone level, is 15-46 ng/dL for a reproductive aged normal menstrual cycles woman . The results demonstrate that there is a diurnal rhythm of testosterone secretion during in girls, with the highest levels in the morning 6 am-10 am .Biochemical hyperandrogenism (TT \>46 ng/dl)
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed case of PCOS Age 18 years to 45 years Exclusion Criteria: * Pregnancy, lactating women Diagnosed case of diabetes mellitus, liver disease, heart disease, kidney stones and disease, Tuberculosis, hyperparathyroidism Patients receiving vitamin D, calcium supplementation within the last two months Known hypersensitivity to Vitamin D Patients unwilling to participate or unwilling to give written consent
References
Publications (0)
Data not yet available
No reference posted for this study.