Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Status:
Recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
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.