Effect of Vitamin D Supplementation on Fasting Glucose and Interleukin-10 (IL-10) in Arab Women With Impaired Fasting Glucose

Summary

Obesity, and its metabolic consequences - impaired fasting glucose (IFG) and diabetes, is highly prevalent among Arab women in Israel and the Middle East. Since life style modification is difficult to achieve in this population it is important to assess whether other modifiable risk factors can be detected. There is evidence that the homeostasis of vitamin D has a significant role in the eventual development of diabetes. Previous cross sectional studies have shown that low 25 (OH) vitamin D levels are related to glucose intolerance, diabetes, insulin resistance and metabolic syndrome. The study hypothesis is that 25(OH) vitamin D deficiency is highly prevalent among Arab women with IFG and that vitamin D supplementation may improve IFG and by that reduce the risk for future overt diabetes. Additionally, obesity is associated with a low-grade inflammation of white adipose tissue (WAT) resulting from chronic activation of the innate immune system. In obesity, there is an increased production and secretion of a wide range of inflammatory molecules including interleukin-10 (IL-10), which may have systemic effects on WAT and other organs. To that end the investigators will assess the influence of vitamin D supplementation on IL-10 and hs-CRP.

Conditions

• Obesity

Interventions

DRUG

Oral vitamin D 100,000 IU

Oral vitamin D 100,000 IU once a month for three consecutive months.

DRUG

Placebo

similar placebo once a month for three consecutive months

Sponsors & Collaborators

• Rambam Health Care Campus

  collaborator OTHER

• Clalit Health Services

  lead OTHER

Principal Investigators

• Naim Shehadeh, MD · Faculty of Medicine, Technion, Haifa,

• Uzi Milman, MD · Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District and the Department of Family Medicine, Faculty of Medicine, Technion- Israel Institute of Technology, HAIFA, ISRAEL.

• Sophia Ish-Shalom, MD · Faculty of Medicine, Technion, Haifa,

• Gila Rosen, PhD · Rambam Health Care Campus

• Mira Barak,, PhD · Clalit Health Services, Haifa and Western Galilee District

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2009-10-31

Completion

2009-10-31

Countries

• Israel

Study Locations