Clinical trial NCT02164552: Vitamin D Status in Relation to Insulin Sensitivity Among Saudi Women With Polycystic Ovary Syndrome
Official title: Vitamin D Status in Relation to Insulin Sensitivity, Resistance and Inflammatory Response Among Saudi Women With Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
vitamin D
insulin resistance
glycemic control
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 340
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Correction of vitamin D deficiency improves insulin resistance compared to placebo
timeFrame: 24 weeks
Secondary outcomes:
measure: Insulin sensitivity
timeFrame: 24 weeks
Other outcomes:
measure: Exploratory and safety outcome
timeFrame: 24 weeks
measure: Exploratory outcomes: lipid profile
timeFrame: 24 weeks
measure: Exploratory outcomes: liver and renal function tests
timeFrame: 24 weeks
measure: Exploratory outcomes: glycemic control
timeFrame: 24 weeks
measure: Exploratory outcomes: vitamin D status
timeFrame: 24 weeks
measure: Exploratory outcomes: endocrine profile
timeFrame: 24 weeks
Locations:
city: Jeddah
country: Saudi Arabia
facility: Center of Excellence for Osteoporosis Research, King Abdulaziz University
state: Makkah
Study officials:
affiliation: Center of Excellence for Osteoporosis Research and Faculty of Medicine, King Abdulaziz University
name: Abdulrahim A Rouzi, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Center of Excellence for Osteoporosis Research, and Faculty of Medicine, King Abdulaziz University
name: Mohammed-Salleh M Ardawi, PhD, FRCPath
role: STUDY_DIRECTOR
References: