A Phase 1 interventional study of Vitamin D and Active Comparator in Anovulatory Infertility, sponsored by Aga Khan University. Recruiting at 1 site in Pakistan. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-18.
Sponsored by Aga Khan University · Phase 1, Interventional, and Treatment
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.
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 given Vitamin D (VD) supplementation at a dose of 600,000 IU along with Calcium 1000 mg/day.
Mid-Point (At 12 weeks):
Patients will have a consultation for clinical interpretation. They will undergo biochemical assessment, including the estimation of Insulin Resistance, Free Androgen Index, and Total Antioxidant Capacity.
After 12 weeks They will receive standard treatment for Polycystic Ovary Syndrome (PCOS), which includes 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 and Calcium 1000 mg/day
Intervention Details for Group B (Duration 1-12 weeks):
Participants in Group B will receive standard PCOS treatment mentioned earlier:
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. Additionally, they receive Calcium 1000 mg/day.
Mid-Point (At 12 weeks):
Patients will have a consultation for clinical interpretation. They will undergo biochemical assessment, including the estimation of Insulin Resistance, Free Androgen Index, and Total Antioxidant Capacity.
Intervention Details for Group A (After 12 weeks)
They will receive VD supplementation (600,000 IU) during this time and continue to receive Calcium 1000 mg/day.
Calculations of HOMA-IR and Free Androgen Index will be done at 12 and 24 weeks and the results will be compared.
{HOMA-IR: HOMA- IR index, a commonly used marker of IR, will be calculated using the formula: HOMA-IR = fasting glucose levels [mmol/L] × fasting insulin levels [μU/mL]/22.5 Free Androgen Index will be derived from TT and SHBG, normally measured in nanomoles per liter. FAI =100 (TT /SHBG)}
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 175 are open to participants now.
This study's planned enrollment of 142 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Aga Khan University is the lead sponsor of 290 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Experimental Group (Group A; n=71): The intervention (experimental) group will receive VD injections 600,000 I.U I/M once with 1 gram calcium supplemental 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.
Drug: Vitamin D
Control Group (Group B; n=71): Participants will receive standard PCOS treatment; Glucophage XR 750 mg once at dinner for 15 days then twice daily and Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off for initial-- 12 weeks. Then VD supplementation (600,000 IUI/M) will be given once during the study period with Calcium 1000 mg/day and continued Standard PCOS treatment from 12- 24 weeks
Other: Active Comparator
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
Also known as: Experimental, Group A
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
Also known as: Group B
hyperandrogenism
hyperandrogenism by Free Androgen Index \[Total Testosterone, Steroid Hormone Binding Globulin
Time frame: 24 weeks
insulin Resistance
HOMA-IR (serum Insulin, Fasting Blood Glucose)
Time frame: 24 weeks
oxidative stress
Total Antioxidant Capacity
Time frame: 24 weeks
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Plan to share: No
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Aga Khan University