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| Sponsors and Collaborators: |
Clalit Health Services Rambam Health Care Campus |
|---|---|
| Information provided by: | Clalit Health Services |
| ClinicalTrials.gov Identifier: | NCT00877123 |
Purpose
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-6 (IL-6), 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-6 and hs-CRP.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: Oral vitamin D 100,000 IU Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Prospective, Randomized, Double Blind Placebo Controled Clinical Trial to Assess the Effect of Vitamin D Supplementation on Fasting Glucose and IL-6 in Arab Women With Impaired Fasting Glucose. |
| Estimated Enrollment: | 80 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Vitamin D: Experimental
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.
|
| Placebo: Placebo Comparator |
Drug: Placebo
similar placebo once a month for three consecutive months
|
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-6 and hs-CRP.
Eligibility| Ages Eligible for Study: | 40 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Uzi Milman, MD | 972-50-6261360 | uzimy@netvision.net.il ; uzimi@clalit.org.il |
| 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 Bar ak,, PhD | Clalit Health Services, Haifa and Western Galilee District |
More Information
| Responsible Party: | Clinical Research Unit, Clalit Health Services, Haifa District HAIFA, ISRAEL. ( Uzi Milman ) |
| Study ID Numbers: | K-09-43-CTIL |
| Study First Received: | April 6, 2009 |
| Last Updated: | April 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00877123 History of Changes |
| Health Authority: | Israel: Ministry of Health |
|
fasting glucose obesity arab women |
interleukin diabetes impaired fasting glucose (IFG) |
|
Body Weight Signs and Symptoms Obesity Vitamin D Vitamins Diabetes Mellitus |
Nutrition Disorders Trace Elements Bone Density Conservation Agents Overweight Overnutrition Micronutrients |
|
Obesity Growth Substances Physiological Effects of Drugs Overweight Bone Density Conservation Agents Pharmacologic Actions Body Weight |
Signs and Symptoms Vitamin D Vitamins Nutrition Disorders Overnutrition Micronutrients |
