Vitamin D Status in Relation to Insulin Sensitivity Among Saudi Women With Polycystic Ovary Syndrome (CEOR-04-08)

Vitamin D Status in Relation to Insulin Sensitivity, Resistance and Inflammatory Response Among Saudi Women With Polycystic Ovary Syndrome

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.

Study Overview

• Status: Unknown
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Dietary supplement: Vitamin D3 pills; Other: Placebo pills

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 Type: Observational
• Enrollment (Anticipated): 340

Contacts and Locations

Study Locations

• Saudi Arabia
  • Makkah
    • Jeddah, Makkah, Saudi Arabia, 21589
      • Recruiting
      • Center of Excellence for Osteoporosis Research, King Abdulaziz University
      • Contact: Veronica B Orbacedo, BSc; Phone Number: 25574 0096612640000; Email: vorbacedo@yahoo.com
      • Contact: Ramia Al-sobhi, BSc; Phone Number: 25528 0096612640000; Email: ceor@kau.edu.sa
      • Sub-Investigator: Ahmed Y Ali, MD
      • Sub-Investigator: Ghazi Y Refai, MD
      • Sub-Investigator: Mohammed H Qari, FRCPA
      • Sub-Investigator: Heba S Kary, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women were recruited through Infertility clinics at King Abdulaziz University Hospital, New Jeddah Clinic Hospital and Dr S Fakeeh Hospital, Jeddah area during general health survey and consecutively referred to a special clinic at the Center of Excellence for Osteoporosis Research for enrollment at the present study

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vitamin D3 pills; Vitamin D3 (cholecalciferol) supplementation (50,000 IU/week for 8 weeks) followed by 1000 IU/day for 16 weeks	Dietary supplement: Vitamin D3 pills; Dietary supplement; Other Names: Vitamin D3; (cholecalciferol)
Placebo pill; Placebo pills will be given 1 per week for 8 weeks followed by 1 per day for 16 weeks	Other: Placebo pills; Placebo pills similar in appearance and shape but without vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correction of vitamin D deficiency improves insulin resistance compared to placebo	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.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin sensitivity	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	24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory and safety outcome	Other endpoints were changes in inflammatory markers (hs-CRP)	24 weeks
Exploratory outcomes: lipid profile	Other endpoints were changes in lipid profile (total cholesterol, HDL-c, LDL-c, and triglycerides)	24 weeks
Exploratory outcomes: liver and renal function tests	Other endpoints were changes in liver function tests [albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase(ALP)]; renal function tests (cystatine C, uric acid, urea) and parathyroid hormone (PTH)	24 weeks
Exploratory outcomes: glycemic control	Other endpoints were changes in HbA1c, fasting plasma glucose and fasting plasma insulin	24 weeks
Exploratory outcomes: vitamin D status	Other endpoints were changes in serum 25-hydroxyvitamin D	24 weeks
Exploratory outcomes: endocrine profile	Other endpoints were changes in (follicle-stimulating hormone, luteinizing hormone, prolactin, thyroid-stimulating hormone, free thyroxine, total testosterone, dehydroepiandrosterone (DHEA), DHEA sulfate, delta 4-androstenedione and sex-hormone binding globulin).	24 weeks

Collaborators and Investigators

• Sponsor: King Abdulaziz University
• Investigators: Principal Investigator: Abdulrahim A Rouzi, FRCPC, Center of Excellence for Osteoporosis Research and Faculty of Medicine, King Abdulaziz University; Study Director: Mohammed-Salleh M Ardawi, PhD, FRCPath, Center of Excellence for Osteoporosis Research, and Faculty of Medicine, King Abdulaziz University

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: June 12, 2014
• First Posted (Estimate): June 16, 2014

Study Record Updates

• Last Update Posted (Estimate): June 16, 2014
• Last Update Submitted That Met QC Criteria: June 12, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: PCOS; insulin resistance; vitamin D; glycemic control
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Hyperinsulinism; Polycystic Ovary Syndrome; Syndrome; Insulin Resistance; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: CEOR-04-08; Vitamin D PCOS (Other Grant/Funding Number: CEOR/001-08 and CEOR/004-08)