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

NCT06045351 | Recruiting Phase 1 DMC

• 1 other identifier: AKUBBS
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anovulatory Infertility

Keywords

Poly cystic Ovarian Syndrome; randomized open label trial; delayed-start design; vitamin D; Pakistan

Outcome Measures

Primary Outcomes (3)

• hyperandrogenism

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

  24 weeks

• insulin Resistance

  HOMA-IR (serum Insulin, Fasting Blood Glucose)

  24 weeks

• oxidative stress

  Total Antioxidant Capacity

  24 weeks

Study Arms (2)

VD supplementation

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

Interventions

Vitamin D DRUG

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

VD supplementation

Active Comparator OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Recently diagnosed PCOS with presence of at least 2 of these 3 elements: clinical or biochemical 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.

You may not qualify if:

• 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 than the normal limit, chronic
• Kidney disease or serum creatinine \>2.0 mg/dL,
• Drug Therapies: VD replacement ; participants who had received VD injection in the 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 insulin sensitivity 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 in the previous 3 months prior to study
• Suffering from congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, type 2 Diabetes Mellitus, renal, hepatic or thyroid disorders, hyperparathyroidism, malabsorption syndromes, Chronic Kidney Disease, Hepatic failure, cystic fibrosis, vaginal bleeding of unknown etiology or /and suffering from COVID-19 (within 3 months).

Sponsors & Collaborators

• Aga Khan University: lead
• Pakistan Science Foundation: collaborator

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 75500, Pakistan

RECRUITING

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Rehana Rehman, PhD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rehana Rehman, PhD

CONTACT

00922134864460; drrehana7@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Infertile females with Polycystic Ovarian Syndrome

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 21, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)