Effect of Vitamin D Supplementation on Fasting Glucose and Interleukin-10 (IL-10) in Arab Women With Impaired Fasting Glucose
|ClinicalTrials.gov Identifier: NCT00877123|
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : November 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Drug: Oral vitamin D 100,000 IU Drug: Placebo||Phase 4|
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.
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 (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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.|
|Study Start Date :||June 2009|
|Primary Completion Date :||October 2009|
|Study Completion Date :||October 2009|
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.
|Placebo Comparator: Placebo||
similar placebo once a month for three consecutive months
- fasting glucose [ Time Frame: 4 months ]
- interleukin-10 level [ Time Frame: 4 months ]
- hs-CRP level [ Time Frame: 4 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00877123
|Clalit Health Services, Haifa and Western Galilee District|
|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|