Status:
COMPLETED
Treatment of Vitamin D Insufficiency
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Conditions:
Vitamin D Deficiency
Eligibility:
FEMALE
Up to 75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to answer the following questions: Does vitamin D increase calcium absorption, bone mass and muscle mass and function in women past menopause who have mildly low vitamin D...
Detailed Description
Osteoporosis is a major health problem in postmenopausal women. At age 50, half of women will suffer an osteoporotic fracture in their remaining lifetime, causing increased disability and mortality. V...
Eligibility Criteria
Inclusion
- Vitamin D insufficiency, defined as a serum 25(OH)D 16 to 25 ng/mL by high performance liquid chromotography assay
- Women ≥ 5 years past the date of last menses or bilateral oophorectomy, or ≥ 60 years old if they had prior hysterectomy without bilateral oophorectomy
- Total dietary and supplemental calcium intake \< 600 mg daily but ≤ 1,400 mg daily, based on a food frequency questionnaire
Exclusion
- Women \> 75 years old
- Hypercalcemia (serum calcium corrected for albumin \> 10.4 mg/dL)
- Nephrolithiasis by medical record or patient report
- Inflammatory bowel disease, malabsorption or chronic diarrhea
- Stage 3, 4 or 5 Chronic Kidney Disease based on the Modification of Renal Diet (MDRD) formula
- Use of bone-active medications within the past 6 months including bisphosphonates, estrogen compounds, calcitonin, teriparatide, oral corticosteroids and anticonvulsants
- Allergy or intolerance to orange juice
- Allergy or intolerance to sunscreen
- Prior adult clinical fragility fracture of the hip, spine or wrist or a T-score below -2.5 at the lumbar spine or femur
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00933244
Start Date
April 1 2010
End Date
August 1 2014
Last Update
November 10 2015
Active Locations (1)
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1
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53705