Actively Recruiting
Vitamin D and Polycystic Ovarian Syndrome (PCOS)
Led by Aga Khan University · Updated on 2025-02-19
300
Participants Needed
2
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Vitamin D and Polycystic Ovarian Syndrome (PCOS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 36 years
- Diagnosed with primary infertility and PCOS with at least two of these: hyperandrogenism, chronic anovulation, and polycystic ovaries
- Vitamin D deficiency with serum levels below 25 nmol/L
- From any ethnic background
You will not qualify if you...
- Secondary infertility
- Hypercalcemia with plasma calcium concentrations above 2.65 mmol/L
- Tuberculosis or other granulomatous disorders
- Current use of vitamin D replacement, oral contraceptives, hormonal replacement therapy, glucocorticoids, calcium supplements, insulin-sensitizing drugs, lipid-lowering drugs, or other drugs affecting insulin sensitivity or serum androgens in the past 3 months
- Use of anti-epileptics, anti-retroviral drugs, cholestyramine, anti-fungal, statins, H2 blockers, immunosuppressants, chemotherapeutic agents, or antimicrobials affecting lipid metabolism in the past 3 months
- Diagnosis of 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 cause
- History of bariatric surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Dr Rehana Rehman
Karachi, Sindh, Pakistan, 74800
Actively Recruiting
2
Dr Rehana Rehman
Karachi, Sindh, Pakistan, 75500
Actively Recruiting
Research Team
R
Rehana K Rehman, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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