Vitamin D and Adipose Tissue Inflammation

Completed · Not applicable

Conditions studied: Vitamin D Deficiency, Obesity, Type 2 Diabetes Mellitus, Intestinal Permeability

In brief

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 deficiency predisposes individuals to the development of adipose tissue inflammation, and that treatment of vitamin D deficient subjects with high dose vitamin D will reduce adipose tissue inflammation.

Key facts

Study ID

NCT01477034

Run by

Fred Hutchinson Cancer Center

People needed

18

Starts

2011-11-01

Expected to finish

2013-06-01

Last updated by the study team

2014-04-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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