Treatment of Vitamin D Insufficiency
Completed · Phase 4 · Has a placebo group
Conditions studied: Vitamin D Deficiency
In brief
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 levels? Do these benefits require prescription-strength vitamin D, or is an over the counter vitamin D dose enough?
Key facts
- Study ID
- NCT00933244
- Run by
- University of Wisconsin, Madison
- People needed
- 230
- Starts
- 2010-04-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2015-11-10
Who can join
Age: any, up to 75. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Wisconsin School of Medicine and Public Health — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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