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

Polycystic Ovary Syndrome Clinical Trial

— CEOR-04-08  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02164552
• Other study ID #: CEOR-04-08
• Secondary ID: Vitamin D PCOS
• Status: Recruiting
• Phase: Phase 2
• First received: June 10, 2014
• Last updated: June 12, 2014
• Start date: January 2009
• Est. completion date: December 2014

Study information

• Verified date: June 2014
• Source: King Abdulaziz University
• Contact: Mohammed-Salleh M Ardawi, PhD, FRCPath
• Phone: 00966505616804
• Email: msmardawi[@]yahoo.com
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry for Higher Education
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Vitamin D3 pills
Dietary supplement

Other:
• Placebo pills
Placebo pills similar in appearance and shape but without vitamin D

Locations

Country	Name	City	State
Saudi Arabia	Center of Excellence for Osteoporosis Research, King Abdulaziz University	Jeddah	Makkah

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory and safety outcome	Other endpoints were changes in inflammatory markers (hs-CRP)	24 weeks	Yes
Other	Exploratory outcomes: lipid profile	Other endpoints were changes in lipid profile (total cholesterol, HDL-c, LDL-c, and triglycerides)	24 weeks	Yes
Other	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	Yes
Other	Exploratory outcomes: glycemic control	Other endpoints were changes in HbA1c, fasting plasma glucose and fasting plasma insulin	24 weeks	Yes
Other	Exploratory outcomes: vitamin D status	Other endpoints were changes in serum 25-hydroxyvitamin D	24 weeks	Yes
Other	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	Yes
Primary	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	Yes
Secondary	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	Yes