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

NCT ID: NCT02164552

Last Updated: 2014-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 340 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2014-12-31

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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Vitamin D3 pills

Vitamin D3 (cholecalciferol) supplementation (50,000 IU/week for 8 weeks) followed by 1000 IU/day for 16 weeks

Vitamin D3 pills

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplement

Placebo pill

Placebo pills will be given 1 per week for 8 weeks followed by 1 per day for 16 weeks

Placebo pills

Intervention Type: OTHER

Placebo pills similar in appearance and shape but without vitamin D

Interventions

Vitamin D3 pills

Dietary supplement

Intervention Type: DIETARY_SUPPLEMENT

Placebo pills

Placebo pills similar in appearance and shape but without vitamin D

Intervention Type: OTHER

Other Intervention Names

Vitamin D3; (cholecalciferol)

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

King Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed-Salleh M. Ardawi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdulrahim A Rouzi, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Center of Excellence for Osteoporosis Research and Faculty of Medicine, King Abdulaziz University

Mohammed-Salleh M Ardawi, PhD, FRCPath

Role: STUDY_DIRECTOR

Center of Excellence for Osteoporosis Research, and Faculty of Medicine, King Abdulaziz University

Locations

Center of Excellence for Osteoporosis Research, King Abdulaziz University

Jeddah, Mecca Region, Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Mohammed-Salleh M Ardawi, PhD, FRCPath

Role: CONTACT

msmardawi@yahoo.com

00966505616804

Abdulrahim A Rouzi, FRCPC

Role: CONTACT

aarouzi@gmail.com

00966505602587

Facility Contacts

Veronica B Orbacedo, BSc

Role: primary

vorbacedo@yahoo.com

0096612640000 ext. 25574

Ramia Al-sobhi, BSc

Role: backup

ceor@kau.edu.sa

0096612640000 ext. 25528

Other Identifiers

Vitamin D PCOS

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CEOR-04-08

Identifier Type: -

Identifier Source: org_study_id