Status:
COMPLETED
Vitamin D and Adipose Tissue Inflammation
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
University of Washington
Conditions:
Vitamin D Deficiency
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Chronic, low-grade adipose tissue inflammation is a major risk factor for type 2 diabetes mellitus. The cause of adipose tissue inflammation has remained largely unclear. We hypothesize that vitamin D...
Detailed Description
The objective of this project is to investigate whether vitamin D modulates chronic low-grade adipose tissue inflammation in overweight and obese, vitamin D deficient men and women. Obesity is associ...
Eligibility Criteria
Inclusion
- Age: 18-65 years;
- BMI ≥25 kg/m2;
- Plasma 25-OH-vitamin D between 7 and 20 ng/mL
- Weight stable to within 10 pounds for 6 months prior to entering the study, and within 30 pounds of their lifetime maximum weight (excluding pregnancy);
- Ability to be admitted for \~6.5 hours on three occasions to the FHCRC Prevention Center,
- Ability to provide informed written consent;
- Willingness to take vitamin D3 capsules daily for 6 months
Exclusion
- Chronic disease such as thyroid disease, liver disease, or kidney disease;
- Diabetes mellitus, or fasting glucose \>125 mg/dL;
- Chronic inflammatory condition such as autoimmune disease or inflammatory bowel disease;
- Malabsorption syndromes (untreated celiac disease; condition after stomach or intestinal resection);
- Current or recent (within one month) chronic intake of medications likely to interfere with study endpoints \[(insulin, antidiabetics, anabolic steroids, glucocorticosteroids, statins, blood thinners (warfarin, aspirin), non-steroidal anti-inflammatory drugs (if daily)\];
- Current or recent (within 3 months) intake of vitamin D in excess of 600 IU/day;
- Anemia, recent history (within 3 months) of anemia; recent (within 3 months) blood donation; recent (within 3 months) participation in another study that involved blood draws; or plans to participate in other research that involves blood draws during the study period;
- Pregnancy in the last 6 months, plans to become pregnant during the study period, or current breastfeeding.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01477034
Start Date
November 1 2011
End Date
June 1 2013
Last Update
April 4 2014
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109