Health TrialsbyHealthPanel

Vitamin D and Polycystic Ovarian Syndrome (PCOS)

ConditionsInfertility, FemaleInfertilityVitamin D Deficiency
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-36
SponsorAga Khan University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Vitamin D

    Drug

    Vitamin D supplementation

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Vitamin D supplementExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

• Insulin levels

Decrease in insulin levels 60%

Time frame
24 weeks
2

• serum androgen levels

Decrease in Serum Androgen levels

Time frame
24 weeks

Secondary outcomes

1

Endometrial thickness

increase in endometrial thickness to 2mm

Time frame
24 weeks
2

Lipid Accumulation Product

reduction in lipid accumulation product

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aga Khan University

Lead sponsor

Source ClinicalTrials.gov
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