Status:
RECRUITING
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Lead Sponsor:
Aga Khan University
Collaborating Sponsors:
Pakistan Science Foundation
Conditions:
Anovulatory Infertility
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief 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 po...
Detailed Description
This study will comprise of two groups (A and B) with 71 participants in each group carried for a duration of 24 weeks. Intervention Details for Group A (Duration 1-12 weeks): Participants will be g...
Eligibility Criteria
Inclusion
- 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
- : 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).
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT06045351
Start Date
January 1 2024
End Date
December 31 2026
Last Update
February 18 2025
Active Locations (1)
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1
Aga Khan University Hospital
Karachi, Sindh, Pakistan, 75500