NCT03989778 Vitamin D and Polycystic Ovarian Syndrome (PCOS)
| NCT ID | NCT03989778 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Aga Khan University |
| Condition | Infertility, Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 300 participants in total. It began in 2023-02-01 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Primary Objectives: To evaluate the efficacy of metformin and Vitamin D supplementation on serum insulin and serum androgen levels (Total testosterone, Steroid Hormone Binding Globulin, Free Androgen Index) levels compared metformin alone in infertile Poly cystic ovarian females of reproductive age group. Secondary Objectives: To measure change in endometrial thickness/number of follicles and follicular size by day 12 trans-vaginal ultrasound in the intervention group i.e. combination of metformin and vitamin D supplementation
Eligibility Criteria
Inclusion Criteria: * Females with age range 18- 36 years, from all ethnic background having primary infertility with diagnosis of PCOS when at least 2 of these 3 elements are present: hyperandrogenism, chronic anovulation and polycystic ovaries and Vitamin D deficiency serum levels \< 25 nmol/L Exclusion Criteria: exclusion criteria at baseline will be excluded from the study * Females with secondary Infertility * Hypercalcemia (plasma calcium concentrations\> 2.65 mmol/L) * Exclude women with Tuberculosis or other granulomatous disorders. * Women receiving vitamin D replacement, 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, immunosuppressants, chemotherapeutic agents, antimicrobials (Rifampicin, isoniazid, hydroqychloroquin) or any other drug modifying lipid metabolism in the previous 3 months prior to study * Women with 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 Women Those who had Bariatric surgery will also be excluded.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03989778 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 36 Years, studying Infertility, Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03989778 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03989778 currently recruiting?
Yes, NCT03989778 is actively recruiting participants. Contact the research team at drrehana7@gmail.com for enrollment information.
Where is the NCT03989778 trial being conducted?
This trial is being conducted at Karachi, Pakistan, Karachi, Pakistan.
Who is sponsoring the NCT03989778 clinical trial?
NCT03989778 is sponsored by Aga Khan University. The trial plans to enroll 300 participants.