An interventional study of vitamin D3 and Placebo in Vitamin D Deficiency and Sarcopenia, sponsored by Tufts University. Completed at 1 site in United States. Open to participants aged 60 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-21.
Sponsored by Tufts University · Not applicable, Interventional, and Basic science
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.
Vitamin D may have favorable effects on muscle but evidence is mixed. It appears that subjects with low starting levels of 25-hydroxyvitamin D (25OHD) who receive adequate doses of vitamin D are the most likely to benefit. Vitamin D supplements are being widely recommended, however the amount of vitamin D needed to achieve the desired level of 25-hydroxyvitamin D in the circulation varies widely among individuals. In this randomized, placebo-controlled trial, we will determine whether treating older adults with low starting 25OHD levels for one year with up to 1600 IU per day of vitamin D3 will improve muscle performance (e.g., lower extremity muscle power) and reduce muscle wasting (defined as reducing nitrogen excretion). Subjects in the vitamin D group will initially take 800 IU of vitamin D3 daily. If they have not achieved the desired level of 70 nmol/L after 4 mo, their dose will be doubled to 1600 IU per day for the remainder of the one-year study. The maximal dose of vitamin D3 to be taken in this study,1600 IU per day, is lower than the current safe upper limit of 4,000 IU per day set by the Institute of Medicine. Up to 100 healthy men and women, age 60 years and older will participate in this study. This investigation should increase our understanding of the impact of supplemental vitamin D on muscle performance.
1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.
This study's enrollment of 100 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Tufts University is the lead sponsor of 225 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vitamin D3, 800 IU will be given initially; after 4 months if D level \< 70 nmol/L, increase dose to 1600 IU for remainder of study.
Dietary Supplement: vitamin D3
Placebo, microcrystalline cellulose
Other: Placebo
Dose for intervention arm is 800 IU/day for first 4 months. At 4 months, if vitamin D level \<70 nmol/L, a second 800 IU capsule will be added to regimen (total of 1600 IU/d) for remainder of study.
Also known as: cholecalciferol
Those in the placebo group will receive 1 capsule for first 4 months. At 4 month visit, one capsule will be added to regimen to be taken throughout the remainder of the study.
Also known as: microcystalline cellulose
The effect of supplemental vitamin D3 vs placebo on leg power and nitrogen excretion.
Aim of the study is to look at the effect of supplemental vitamin D3 vs placebo on leg power and nitrogen excretion.To determine Vitamin D will improve leg power and reduce muscle wasting, as measured by 24-hr nitrogen excretion.
Time frame: 12 months
To describe the safety (assessed by serum calcium) of the administered doses of vitamin D3.
To describe the safety (assessed by serum calcium) of the administered doses of vitamin D3.
Time frame: 12 months
To determine the effect of supplemental vitamin D3 vs placebo on SPPB.
To determine the effect of supplemental vitamin D3 vs placebo on SPPB.
Time frame: 12 months
To determine the effect of supplemental vitamin D3 vs placebo on handgrip.
To determine the effect of supplemental vitamin D3 vs placebo on handgrip.
Time frame: 12 months
To determine the effect of supplemental vitamin D3 vs placebo on stair climb.
To determine the effect of supplemental vitamin D3 vs placebo on stair climb.
Time frame: 12 months
To determine the effect of supplemental vitamin D3 vs placebo on backward walking.
To determine the effect of supplemental vitamin D3 vs placebo on backward walking.
Time frame: 12 months
Plan to share: No
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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