Vitamin D and Polycystic Ovarian Syndrome (PCOS)

NCT03989778 | Recruiting Phase 2 DMC

• 1 other identifier: 124
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

Primary Objectives: To evaluate the efficacy of metformin and Vitamin D supplementation on serum insulin and serum androgen levels (Total testosterone, Steroid Hormone Binding Globulin, Free Androgen Index) levels compared metformin alone in infertile Poly cystic ovarian females of reproductive age group. Secondary Objectives: To measure change in endometrial thickness/number of follicles and follicular size by day 12 trans-vaginal ultrasound in the intervention group i.e. combination of metformin and vitamin D supplementation

Conditions

Infertility, Female; Infertility; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (2)

• • Insulin levels

  Decrease in insulin levels 60%

  24 weeks

• • serum androgen levels

  Decrease in Serum Androgen levels

  24 weeks

Secondary Outcomes (2)

• Endometrial thickness

  24 weeks

• Lipid Accumulation Product

  24 weeks

Study Arms (2)

Vitamin D supplement

EXPERIMENTAL

The intervention group will receive VD Cholecalciferol (D2) 50,000 I.U once weekly for 12 weeks, followed by 50,000 I.U once every fortnight for 24 weeks with the Metformin treatment as prescribed by the physician whereas

Drug: Vitamin D

Control

NO INTERVENTION

control group will receive Metformin treatment during the study period.

Interventions

Vitamin D DRUG

Vitamin D supplementation

Also known as: Metformin

Vitamin D supplement

Eligibility Criteria

• Age: 18 Years - 36 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females with age range 18- 36 years, from all ethnic background having primary infertility with diagnosis of PCOS when at least 2 of these 3 elements are present: hyperandrogenism, chronic anovulation and polycystic ovaries and Vitamin D deficiency serum levels \< 25 nmol/L

You may not qualify if:

• Females with secondary Infertility
• Hypercalcemia (plasma calcium concentrations\> 2.65 mmol/L)
• Exclude women with Tuberculosis or other granulomatous disorders.
• Women receiving vitamin D replacement, 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, immunosuppressants, chemotherapeutic agents, antimicrobials (Rifampicin, isoniazid, hydroqychloroquin) or any other drug modifying lipid metabolism in the previous 3 months prior to study
• Women with 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 Women Those who had Bariatric surgery will also be excluded.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (2)

Dr Rehana Rehman

Karachi, Sindh, 74800, Pakistan

RECRUITING

Dr Rehana Rehman

Karachi, Sindh, 75500, Pakistan

RECRUITING

MeSH Terms

Conditions

Infertility, Female; Infertility; Vitamin D Deficiency

Interventions

Vitamin D; Metformin

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Rehana K Rehman, PhD

CONTACT

00922134864460; drrehana7@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Infertile females with Polycystic Ovarian Syndrome

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 18, 2019
• Study Start: February 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: July 13, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)