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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clalit Health Services
• Collaborator: Rambam Health Care Campus
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Arab women, age 40-65

• No significant handicap or disabilities in ADL

• BMI > 25 kg/m2

• IFG of 100-125 mg/dl

Exclusion Criteria:

• Diabetes Mellitus

• Other medical conditions that may have an effect on IFG (cancer, chronic renal failure, inflammatory diseases etc)

• History of vascular disease

• Regular use of medications that may affect IFG (steroids, HRT, diuretics etc)

• Hypercalcemia (albumin corrected Ca >10.3 mg/dl)

• Inability to sign an informed consent due to mental or psychiatric ailment