drugset / Trial / NCT03989778

Vitamin D and Polycystic Ovarian Syndrome (PCOS)

NCT03989778

Phase 2 Recruiting 300 enrolled Aga Khan University
RandomizedSingle-groupOpen-labelTreatment

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

Timeline

Start
2023-02-01
Primary completion
2025-06-30
Completion
2025-07-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Vitamin D Other / unclassified 50000 iu
Background Metformin Small molecule