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

NCT ID: NCT00877123

Last Updated: 2011-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D

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

Group Type EXPERIMENTAL

Oral vitamin D 100,000 IU

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

similar placebo once a month for three consecutive months

Interventions

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Oral vitamin D 100,000 IU

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

Intervention Type DRUG

Placebo

similar placebo once a month for three consecutive months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role collaborator

Clalit Health Services

OTHER

Sponsor Role lead

Responsible Party

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Uzi Milman

Director, 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.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Naim Shehadeh, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Technion, Haifa,

Uzi Milman, MD

Role: PRINCIPAL_INVESTIGATOR

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

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Technion, Haifa,

Gila Rosen, PhD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Mira Barak,, PhD

Role: PRINCIPAL_INVESTIGATOR

Clalit Health Services, Haifa and Western Galilee District

Locations

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Clalit Health Services, Haifa and Western Galilee District

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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K-09-43-CTIL

Identifier Type: -

Identifier Source: org_study_id