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

Prospective, Randomized, Double Blind Placebo Controled Clinical Trial to Assess the Effect of Vitamin D Supplementation on Fasting Glucose and IL-10 in Arab Women With Impaired Fasting Glucose.

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Oral vitamin D 100,000 IU; Drug: Placebo

Detailed Description

Eligible women will be invited by their primary care physician to participate in the study. After signing an informed consent women will be randomized to receive oral vitamin D 100,000 IU or similar placebo once a month for three consecutive months. Pertinent clinical and demographic date will be documented and relevant laboratory test will be performed by the primary care team. One month after the third dose the same data and tests will be retrieved on each woman. Compliance with the study protocol will be enhanced and confirmed by a research assistant.

Objectives:

To assess the relationship between IFG and 25(OH) vitamin D levels in overweight Arab women.

To assess whether vitamin D supplementation significantly improves IFG. To assess whether vitamin D supplementation significantly modifies IL-10 and hs-CRP.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Clalit Health Services, Haifa and Western Galilee District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; similar placebo once a month for three consecutive months
Experimental: Vitamin D; Intervention arm: Oral vitamin D 100,000 IU once a month for three consecutive months.	Drug: Oral vitamin D 100,000 IU; Oral vitamin D 100,000 IU once a month for three consecutive months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
fasting glucose	4 months
interleukin-10 level	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
hs-CRP level	4 months

Collaborators and Investigators

• Sponsor: Clalit Health Services
• Collaborators: Rambam Health Care Campus
• Investigators: Principal Investigator: Naim Shehadeh, MD, Faculty of Medicine, Technion, Haifa,; Principal Investigator: 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.; Principal Investigator: Sophia Ish-Shalom, MD, Faculty of Medicine, Technion, Haifa,; Principal Investigator: Gila Rosen, PhD, Rambam Health Care Campus; Principal Investigator: Mira Barak,, PhD, Clalit Health Services, Haifa and Western Galilee District

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: April 6, 2009
• First Submitted That Met QC Criteria: April 6, 2009
• First Posted (Estimate): April 7, 2009

Study Record Updates

• Last Update Posted (Estimate): November 10, 2011
• Last Update Submitted That Met QC Criteria: November 9, 2011
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: diabetes; obesity; impaired fasting glucose (IFG); interleukin; fasting glucose; arab women
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: K-09-43-CTIL