Status:
COMPLETED
Vitamin D Supplementation in Older Women
Lead Sponsor:
Creighton University
Collaborating Sponsors:
National Institute on Aging (NIA)
Office of Dietary Supplements (ODS)
Conditions:
Osteoporosis
Aging
Eligibility:
FEMALE
57+ years
Phase:
NA
Brief Summary
The purpose of this study is to examine the effects of several doses of vitamin D on hormones related to bone, calcium absorption, bone density and muscle strength.
Detailed Description
The prevalence of osteoporosis is high in the United States, with about 10 million people over the age of 50 already having the disease and another 34 million at risk for developing it. Development of...
Eligibility Criteria
Inclusion
- At least 7 years post-menopause
- Serum 25OHD level 5 ng/ml to 20 ng/ml
- BMI less than or equal to 40 kg/m2
- Willing to discontinue multivitamins that contain vitamin D during the study
Exclusion
- Cancer (except basal cell carcinoma) or terminal illness
- Previous hip fracture
- Hemiplegia (paralysis of one side of the body)
- Uncontrolled type I diabetes or fasting blood sugar greater than 140 mg in type II
- Kidney stones more than twice in a lifetime
- Chronic renal failure
- Evidence of chronic liver disease, including alcoholism
- Physical conditions such as severe osteoarthritis, rheumatoid arthritis, heart failure severe enough to prevent reasonable physical activity
- Previous treatment with bisphosphonates (more that 3 months), PTH or PTH derivatives, (e.g. Teriparatide or Fluoride) in the last 6 months
- Previous treatment within the last 6 months with calcitonin or estrogen
- Chronic high dose corticosteroid therapy (more than 10 mg per day) for over 6 months and not within the last 6 months
- Anticonvulsant therapy
- High dose thiazide therapy (more than 37.5 mg)
- 24 hour urine calcium greater than 290 mg on 2 baseline tests
- Serum calcium exceeding upper normal limit on 2 baseline tests
- Bone Mineral Density T-score less than -3.0 for spine or hip
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT00472823
Start Date
April 1 2007
End Date
August 1 2011
Last Update
March 14 2016
Active Locations (1)
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1
Creighton University Medical Center
Omaha, Nebraska, United States, 68131