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

Last updated: February 17, 2025
Sponsor: Aga Khan University
Overall Status: Active - Recruiting

Phase

1

Condition

Infertility

Reproductive Health

Polycystic Ovarian Syndrome

Treatment

Active Comparator

Vitamin D

Clinical Study ID

NCT06045351
AKUBBS
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Recently diagnosed PCOS with presence of at least 2 of these 3 elements: clinical orbiochemical signs of hyperandrogenism, chronic anovulation and polycystic ovaries (1) (from reports of available routine TVS), with VDD serum levels VD <20 ng/ml(10),age range 18- 45 years, from all ethnic background will be included.

Exclusion

Exclusion Criteria:

  • : Exclusion of subjects will be done by the Co-Principal Investigators (Co-PI) afterhistory, examination and complete evaluation in the respective clinics. All femalesubjects meeting any of the following criteria will be excluded from the study

  • Pregnancy

  • Hypercalcemia (plasma calcium concentrations> 2.65 mmol/L)

  • Tuberculosis or other granulomatous disorders

  • Chronic liver disease or alanine transaminase (ALT) level 3 times higher thanthe normal limit, chronic

  • Kidney disease or serum creatinine >2.0 mg/dL,

  • Drug Therapies: VD replacement ; participants who had received VD injection inthe last 3 months prior to recruitment in the study, oral contraceptives,hormonal replacement therapy, glucocorticoids, calcium supplementation,insulin-sensitizing drugs (incretin mimetic drugs, thiazolidinedione,sulfonylurea), lipid-lowering drugs or other drugs affecting insulinsensitivity or serum androgens (e.g., niacin, corticosteroids, beta-blockers,calcium channel blockers, thiazide diuretics), anti-epileptics,anti-retroviral, cholestyramine, anti-fungal, statins, H2 blockers,immunosuppressant, chemotherapeutic agents, antimicrobials (Rifampicin,Isoniazid, Hydroxychloroquine) or any other drug modifying lipid metabolism inthe previous 3 months prior to study

  • Suffering from congenital adrenal hyperplasia, Cushing's syndrome,androgen-secreting tumors, type 2 Diabetes Mellitus, renal, hepatic or thyroiddisorders, hyperparathyroidism, malabsorption syndromes, Chronic KidneyDisease, Hepatic failure, cystic fibrosis, vaginal bleeding of unknown etiologyor /and suffering from COVID-19 (within 3 months).

Study Design

Total Participants: 142
Treatment Group(s): 2
Primary Treatment: Active Comparator
Phase: 1
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2026

Study Description

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)}

Connect with a study center

  • Aga Khan University Hospital

    Karachi, Sindh 75500
    Pakistan

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.