Sunweavers: Supporting Native American Women's Vitamin D Research

Completed · Phase 2

Conditions studied: Vitamin D Deficiency, Cardiovascular Diseases

In brief

Cardiovascular disease (CVD) and diabetes occur commonly among Native Americans (NA), and are leading causes of death among northern US NAs. Moreover, low vitamin D status occurs commonly in this same population. An increasing amount of evidence indicates a correlation between low vitamin D status and CVD and diabetes by contributing to a heightened pro-inflammatory environment within the endothelial lining of blood vessels leading to atherosclerotic disease, and an impaired sensitivity to insulin leading to diabetes. Our fundamental hypothesis is that low vitamin D status is a risk factor for CVD by causing a proinflammatory milieu, thereby leading to endothelial dysfunction. Additionally, the investigators hypothesize that vitamin D supplementation will reduce inflammation, thereby restoring endothelial function and ultimately reducing CVD risk.

Key facts

Study ID

NCT01490333

Run by

University of Wisconsin, Madison

People needed

99

Starts

2011-07-01

Expected to finish

2014-04-01

Last updated by the study team

2014-11-20

Who can join

Age: 55 and older, up to 75. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Ambulatory, community dwelling AI woman
• Postmenopausal up to age 75 years; for women below age 55, postmenopausal status must be confirmed by documentation of serum FSH>30 IU/L and estradiol < 20 pg/ml unless a bilateral oophorectomy is documented.

You may not qualify if…

• Serum 25(OH)D < 10 or > 60 ng/ml.
• Known CVD (history of MI, coronary artery bypass graft surgery, percutaneous coronary intervention, stroke, transient ischemic attack, peripheral arterial disease with claudication).
• Uncontrolled thyroid disease (thyroid stimulating hormone level outside of normal range).
• Change in dose of lipid lowering medications within the preceding six weeks.
• Mastectomy of the right breast
• Non-English speaking, illiterate, impaired decision making.

Where it is running

• Stockbridge-Munsee Nation — Bowler, Wisconsin, United States
• Bad River Nation — Lac du Flambeau, Wisconsin, United States
• University of Wisconsin Osteoporosis Clinical Research Program — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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