University of California
San Francisco, California, 94143, United States
NCT Number: NCT01554241
Vitamin D deficiency is highly prevalent in older people in the absence of vitamin D supplementation. The limited data available show marked inter-individual variability in response to vitamin D supplementation in very old, frail elderly with almost 25% remaining vitamin D deficient (25-OH D < 20 ng/mL) when receiving the currently recommended 800 IU/day vitamin D. This proposal is for exploratory research on the use of a wide range of oral vitamin D3 doses in frail elderly living in controlled living environments.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
San Francisco, California, 94143, United States
The investigators will determine the dose response relationship of circulating total and unbound 25-OH vitamin D3 to supplemental vitamin D3 at daily doses of 800 (currently recommended for the elderly), 2000, and 4000 IU or 50,000 IU/weekly in a randomized blinded investigation of 16 weeks duration. The investigators will also compare the efficacy of each dosing regimen in achieving 25-OH vitamin D levels >20 ng/mL (50 nmol/L) and identify covariates that contribute to inter-individual variation in the dose response relationship. In patients with osteoporosis, relationships between unbound vs. total 25-OH on intact parathyroid hormone and a marker of bone resorption (beta-Ctx) will be analyzed. The investigators will also examine responses of inflammatory cytokines.
Note: as of April 8,2014, there will be no further enrollment in the 50,000 IU/weekly dose group
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2000 IU/day D3
Other names: cholecalciferol
vitamin D3 4000 IU/day
Other names: cholecalciferol
vitamin D3 50,000 IU/week
Other names: cholecalciferol
vitamin D3 800 IU/day
Other names: cholecalciferol
Time frame: 16 weeks
circulating total 25-OH vitamin D concentration
Time frame: 16 weeks
circulating free 25-OH vitamin D3 concentration
University of California, San Francisco
Other
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