Status:
COMPLETED
Sunweavers: Supporting Native American Women's Vitamin D Research
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Vitamin D Deficiency
Cardiovascular Diseases
Eligibility:
FEMALE
55-75 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Low vitamin D status is endemic due to 21st century lifestyle, which limits sun exposure, and inadequate dietary intake. An increasing body of data relates low vitamin D status to increased risk for n...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT01490333
Start Date
July 1 2011
End Date
April 1 2014
Last Update
November 20 2014
Active Locations (3)
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1
Stockbridge-Munsee Nation
Bowler, Wisconsin, United States, 54416
2
Bad River Nation
Lac du Flambeau, Wisconsin, United States, 54538
3
University of Wisconsin Osteoporosis Clinical Research Program
Madison, Wisconsin, United States, 53705