Vitamin D Status in Relation to Insulin Sensitivity Among Saudi Women With Polycystic Ovary Syndrome

• Conditions: Polycystic Ovary Syndrome
• Interventions: Dietary Supplement: Vitamin D3 pills; Other: Placebo pills

• Registration Number: NCT02164552
• Lead Sponsor: King Abdulaziz University

Brief Summary

The study tests the hypothesis that correction of vitamin D deficiency among women with PCOS will improve insulin sensitivity and resistance and inflammatory response to PCOS.

Detailed Description

Polycystic ovary syndrome (PCOS) is a common complex and heterogenous endocrine disorder. It affects ≤10% of women of reproductive age, with approximately 16%-80% of the affected women being obese. Polycystic ovary syndrome frequently is associated with insulin resistance (IR) accompanied by compensatory hyperinsulinemia, and IR is aggravated by the interaction between obesity and the syndrome. Moreover, the contribution of body mass and/or body fat distribution to IR of PCOS remains controversial. In addition, women with PCOS with IR are at an increased risk of developing diabetes, hypertension, dyslipidemia and atherosclerosis. Preliminary data on the local women with PCOS showed high prevalence of vitamin D deficiency (serum 25(OH)D \< 50 nmol/L). Recent studies showed that vitamin D deficiency is linked to IR, type 2 diabetes mellitus, obesity, inflammation and cardio vascular disease. Several studies have demonstrated that serum 25(OH)D levels were negatively correlated with body mass index (BMI), body fat, and IR. These conditions are common among women with PCOS. Accordingly, it is anticipated that vitamin D deficiency and/or insufficiency may contribute to the endocrine and metabolic disarrangements among women with PCOS. Such adverse effects may further contribute to the risk of further long term complications among women with PCOS.

Study Timeline

• Study Start: 2009-01
• Status Verified: 2014-06
• Primary Completion: 2014-06
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-12
• Last Update Submitted: 2014-06-12
• Study First Posted: 2014-06-16
• Last Update Posted: 2014-06-16
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 340

Inclusion Criteria

PCOS diagnosis to include three of the Rotterdam criteria

Exclusion Criteria

pregnancy lactation taking vitamin d or calcium supplement in excess of a regular multivitamins diabetes mellitus uncontrolled hypertension liver disease renal disease secondary causes of hyperandrogenism metabolic bone disease thyroid dysfunction taking oral contraceptives taking hypoglycemic agents (metformin or thiazolidinediones) medication to affect plasma sex steroids for >/3 months before the study smokers

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vitamin D3 pills	Vitamin D3 pills	Vitamin D3 (cholecalciferol) supplementation (50,000 IU/week for 8 weeks) followed by 1000 IU/day for 16 weeks
Placebo pill	Placebo pills	Placebo pills will be given 1 per week for 8 weeks followed by 1 per day for 16 weeks

Primary Outcome Measures

Name	Time	Method
Correction of vitamin D deficiency improves insulin resistance compared to placebo	24 weeks	The primary endpoint was an improvement in insulin resistance parameters \[Fasting serum insulin,glucose-to-insulin ratio (GIR) and homeostasis model assessment (HOMA) \] from baseline and at 24 weeks in vitamin D supplemented as compared with placebo groups.

Secondary Outcome Measures

Name	Time	Method
Insulin sensitivity	24 weeks	Secondary endpoints were changes in parameter of insulin sensitivity\[ quantitative insulin sensitivity check index (QUICKI)\], among vitamin D supplemented group vs placebo group from baseline and at the end of the trial

Trial Locations

Locations (1)

Center of Excellence for Osteoporosis Research, King Abdulaziz University; 🇸🇦 Jeddah, Makkah, Saudi Arabia