Impact of Vitamin D on 25-hydroxyvitamin D Levels and Physical Function
Completed · Not applicable · Has a placebo group
Conditions studied: Vitamin D Deficiency, Sarcopenia
In brief
This one-year study will test the hypothesis that supplementation with vitamin D will improve lower extremity muscle performance in older men and women with vitamin D insufficiency.
Key facts
- Study ID
- NCT02293187
- Run by
- Tufts University
- People needed
- 100
- Starts
- 2015-03-23
- Expected to finish
- 2018-12-31
- Last updated by the study team
- 2019-03-21
Who can join
Age: 60 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Men and postmenopausal women age 60 years and older
- Women must be at least 1 year since last menses.
- Subjects must agree not to take their own vitamin D in amounts >600 IU/day (for ages 51-70 years) or >800 IU/day (for ages 71 - 80 years) or more than 600 mg/day of supplemental calcium.
- Subjects must agree not to have had more than 30 minutes/day of sun exposure at a southern latitude (< 34 degrees N) in the 2-month period prior to screening and not to travel south and be exposed to sunshine in the 3-month period prior to their final visit.
- They will agree not to use tanning salons during the study.
- Screening serum 25OHD of 20 to 50 nmol/L (8.0 to 20 ng/ml).
You may not qualify if…
- Kidney stones - in the last 3 years
- Calculated glomerular filtration rate < 30 ml/min
- Screening fasting spot urinary calcium:creatinine ratio (Ca:Cr) > 0.325 (corresponding to a 24-hr urine calcium of 350 mg)
- Serum calcium exceeding upper normal limit (reference range 8.3 -10.2 mg/dl)
- Other abnormalities in screening labs, at the discretion of the study physician (PI)
- Sarcoidosis
- Evidence of chronic liver disease, including alcoholism
- Cancer treatment in the last year (except basal cell carcinoma) or terminal illness
- Treatment in the last 6 months with estrogen, raloxifene, calcitonin, or testosterone (vaginal estrogen use okay)
- High dose thiazide therapy (>37.5 mg).
- Treatment in the last year with teriparatide or denosumab
- Treatment in the lsat 2 years with bisphosphonates
- Oral corticosteroid therapy for over 3 weeks within the last 6 months
- Anticonvulsant therapy
- Physical conditions such as osteoarthritis, rheumatoid arthritis, heart failure or hemiplegia severe enough to prevent reasonable physical activity.
- Non-English speaking subjects (We can't be confident that non-English speaking subjects could accurately identify intakes of calcium and vitamin D from non-study sources and this could increase their risk of toxicity from study drug.
- Other abnormalities in screening labs, at the discretion of the study physician (the PI)
Where it is running
- Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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