Vitamin D and Polycystic Ovarian Syndrome (PCOS)

Recruiting now · Phase 2

Conditions studied: Infertility, Female, Infertility, Vitamin D Deficiency

In brief

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

Key facts

Study ID

NCT03989778

Run by

Aga Khan University

People needed

300

Starts

2023-02-01

Expected to finish

2025-07-13

Last updated by the study team

2025-02-19

Who can join

Age: 18 and older, up to 36. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Dr Rehana Rehman — Karachi, Sindh, Pakistan (enrolling)
• Dr Rehana Rehman — Karachi, Sindh, Pakistan (enrolling)

Full record on ClinicalTrials.gov

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