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

King Abdulaziz University

Status: Unknown

Conditions: Polycystic Ovary Syndrome

Treatments: Dietary Supplement: Vitamin D3 pills; Other: Placebo pills

Study type: Observational

Funder types: Other

Identifiers

NCT02164552

CEOR-04-08

Vitamin D PCOS (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 340 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

340 participants in 2 patient groups

Vitamin D3 pills

Description:

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

Treatment:

Dietary Supplement: Vitamin D3 pills

Placebo pill

Description:

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

Treatment:

Other: Placebo pills