Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Gland and Hormone Related Diseases

Syndrome

Infertility

Polycystic Ovary Syndrome

Anovulation

Genital Diseases

Urogenital Diseases

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Micronutrients

Bone Density Conservation Agents

Vitamins

Mineral

Metformin

Vitamin D

Cholecalciferol

Calcium

Calcium, Dietary

Progesterone

Trace Elements

Vitamin D3

Calciferol

Calcium Supplement

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.

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

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

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

Active Comparator

Rehana Rehman, PhD

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)}

Infertile females with Polycystic Ovarian Syndrome

Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome

Efficacy of Vitamin D Supplementation in Females With Polycystic Ovary Syndrome: a Randomized Open Label Delayed-start Design

hyperandrogenism by Free Androgen Index \[Total Testosterone, Steroid Hormone Binding Globulin

HOMA-IR (serum Insulin, Fasting Blood Glucose)

Pakistan Science Foundation

Aga Khan University

Professor

Spots Global Cancer Trial Database for poly cystic ovarian syndrome