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RECRUITING

NCT06045351

PHASE1

Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome

Sponsor: Aga Khan University

View on ClinicalTrials.gov

Summary

Poly cystic Ovarian Syndrome (PCOS) is an endocrine disorder of reproductive age defined by "the presence of any two out of three criteria: oligo and/or anovulation, excess androgen activity and/or polycystic ovarian morphology on ultrasound". Considering role of vitamin D (VD) (3, 4) and high prevalence (58%) of deficiency in PCOS of Pakistan. Researchers hypothesized that its correction would improve response to standard PCOS treatment. The objective is to compare PCOS parameters in intervention group (Group A) receiving VD supplementation and then PCOS care with control group (Group B) receiving standard PCOS care and then VD supplementation. A randomized open label trial: delayed-start design will be conducted on VD deficient PCOS females VD \< 20ng/ml ; Group A will receive VD injections 600,000 I.U I/M once with 1 gram calcium supplement daily in the initial 12 weeks. After that standard PCOS care; i) Glucophage XR 750 mg (once for 15 days then twice daily) ii) progesterone supplementation (1 capsule Progeffik 100 mg every 3 weeks, then 1 week off) and iii) calcium supplements will be given for next 12 weeks. PCOS females in Group B will receive standard PCOS care (same) with addition of VD and calcium supplementation after 12 weeks till study end point. Study outcomes will be comparison of i) hyperandrogenism by Free Androgen Index \[Total Testosterone, Steroid Hormone Binding Globulin ii) insulin Resistance by HOMA-IR (serum Insulin, Fasting Blood Glucose) and iii) oxidative stress by Total Antioxidant Capacity after 24-weeks in these Groups'd levels after supplementation will be assessed for confirmation of correction and calcium and albumin levels for detection of hypercalcemia. Results of this study will inform the clinicians to add VD before or after the standard PCOS care for rectification of endocrine and metabolic derangements as a cost-effective treatment and prevention strategy in these females.

Official title: Efficacy of Vitamin D Supplementation in Females With Polycystic Ovary Syndrome: a Randomized Open Label Delayed-start Design

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

142

Start Date

2024-01-01

Completion Date

2026-12-31

Last Updated

2025-02-18

Healthy Volunteers

Yes

Conditions

Anovulatory Infertility

Interventions

DRUG

Vitamin D

Intervention Group Initial 12 weeks; * VD supplementation (600,000 IU I/M) once during the study period * Elemental calcium 1000 mg/day From 12-24 weeks: Standard PCOS; * Glucophage XR 750 mg once at dinner for 15 days then twice daily * Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off * Calcium 1000 mg/day

OTHER

Active Comparator

Active Comparator (Group B; n=71): Initial-- 12 weeks; * Standard PCOS; * Glucophage XR 750 mg once at dinner for 15 days then twice daily * Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off From 12- 24 weeks * VD supplementation (600,000 IUI/M) once during the study period * Calcium 1000 mg/day * Standard PCOS Continued

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).

Locations (1)

Aga Khan University Hospital

Karachi, Sindh, Pakistan