Injectable Vitamin D for Women with Polycystic Ovary Syndrome
Official title: Efficacy of Vitamin D Supplementation in Females With Polycystic Ovary Syndrome: a Randomized Open Label Delayed-start Design
Run by Aga Khan University · NCT06045351 · Data updated 2026-11-12
This study is testing if giving Vitamin D injections to women with Polycystic Ovary Syndrome and low Vitamin D can help improve their treatment results.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 142 (estimated) |
| Sponsor | Aga Khan University Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | December 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT06045351 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are females aged 18-45 with recently diagnosed PCOS and Vitamin D deficiency.
✕Probably not a fit
Patients who are pregnant, have hypercalcemia, or other specified chronic conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the efficacy of injectable Vitamin D supplementation in women diagnosed with Polycystic Ovary Syndrome (PCOS) who also have Vitamin D deficiency. The study involves two groups: one receiving Vitamin D injections followed by standard PCOS treatment, and the other receiving standard treatment first before Vitamin D supplementation. Participants will be monitored over a 24-week period, with assessments of various PCOS parameters and biochemical markers at the midpoint and conclusion of the trial. The aim is to determine if correcting Vitamin D deficiency improves treatment outcomes for PCOS.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of PCOS treatments by addressing Vitamin D deficiency.
How similar studies have gone: While the role of Vitamin D in PCOS is being explored, this specific approach is novel and has not been extensively tested in similar trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Recently diagnosed PCOS with presence of at least 2 of these 3 elements: clinical or biochemical signs of hyperandrogenism, chronic anovulation and polycystic ovaries (1) (from reports of available routine TVS), with VDD serum levels VD \<20 ng/ml(10), age range 18- 45 years, from all ethnic background will be included. Exclusion Criteria: * : Exclusion of subjects will be done by the Co-Principal Investigators (Co-PI) after history, examination and complete evaluation in the respective clinics. All female subjects meeting any of the following criteria will be excluded from the study * Pregnancy * Hypercalcemia (plasma calcium concentrations\> 2.65 mmol/L) * Tuberculosis or other granulomatous disorders * Chronic liver disease or alanine transaminase (ALT) level 3 times higher than the normal limit, chronic * Kidney disease or serum creatinine \>2.0 mg/dL, * Drug Therapies: VD replacement ; participants who had received VD injection in the last 3 months prior to recruitment in the study, oral contraceptives, hormonal replacement therapy, glucocorticoids, calcium supplementation, insulin-sensitizing drugs (incretin mimetic drugs, thiazolidinedione, sulfonylurea), lipid-lowering drugs or other drugs affecting insulin sensitivity or serum androgens (e.g., niacin, corticosteroids, beta-blockers, calcium channel blockers, thiazide diuretics), anti-epileptics, anti-retroviral, cholestyramine, anti-fungal, statins, H2 blockers, immunosuppressant, chemotherapeutic agents, antimicrobials (Rifampicin, Isoniazid, Hydroxychloroquine) or any other drug modifying lipid metabolism in the previous 3 months prior to study * Suffering from congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, type 2 Diabetes Mellitus, renal, hepatic or thyroid disorders, hyperparathyroidism, malabsorption syndromes, Chronic Kidney Disease, Hepatic failure, cystic fibrosis, vaginal bleeding of unknown etiology or /and suffering from COVID-19 (within 3 months).
Where it's running
-
Aga Khan University Hospital
Karachi, Sindh, Pakistan Recruiting
Study contacts
- Principal investigator: Rehana Rehman, PhD — Aga Khan University
- Study coordinator: Rehana Rehman, PhD
- Email: drrehana7@gmail.com
- Phone: 00922134864460
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.