Status:
COMPLETED
Effect of Vitamin D Supplementation on Fasting Glucose and Interleukin-10 (IL-10) in Arab Women With Impaired Fasting Glucose
Lead Sponsor:
Clalit Health Services
Collaborating Sponsors:
Rambam Health Care Campus
Conditions:
Obesity
Eligibility:
FEMALE
40-65 years
Phase:
PHASE4
Brief 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...
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 p...
Eligibility Criteria
Inclusion
- Arab women, age 40-65
- No significant handicap or disabilities in ADL
- BMI \> 25 kg/m2
- IFG of 100-125 mg/dl
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00877123
Start Date
June 1 2009
End Date
October 1 2009
Last Update
November 10 2011
Active Locations (1)
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1
Clalit Health Services, Haifa and Western Galilee District
Haifa, Israel