Adit A Ginde1, Patrick Blatchford2,3, Keith Breese1, Lida Zarrabi1, Sunny A Linnebur4,5, Jeffrey I Wallace5, Robert S Schwartz3,5. 1. Department of Emergency Medicine, School of Medicine, University of Colorado, Aurora, Colorado. 2. Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado. 3. Geriatric Research, Education and Clinical Center, Eastern Colorado Department of Veterans Affairs, Denver, Colorado. 4. Department of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado. 5. Division of Geriatric Medicine, School of Medicine, University of Colorado, Aurora, Colorado.
Abstract
OBJECTIVES: To determine the efficacy and safety of high-dose vitamin D supplementation for prevention of acute respiratory infection (ARI) in older long-term care residents. DESIGN: Randomized controlled trial investigating high-dose vs standard-dose vitamin D from 2010 to 2014. SETTING: Colorado long-term care facilities. PARTICIPANTS: Long-term care residents aged 60 and older (n = 107). INTERVENTION: The high-dose group received monthly supplement of vitamin D3 100,000 IU, the standard-dose group received a monthly placebo (for participants taking 400-1,000 IU/d as part of usual care) or a monthly supplement of 12,000 IU of vitamin D3 (for participants taking <400 IU/d as part of usual care). MEASUREMENTS: The primary outcome was incidence of ARI during the 12-month intervention. Secondary outcomes were falls and fractures, 25-hydroxyvitamin D levels, hypercalcemia, and kidney stones. RESULTS: Participants (55 high dose, 52 standard dose) were randomized and included in the final analysis. The high-dose group had 0.67 ARIs per person-year and the standard-dose group had 1.11 (incidence rate ratio (IRR) = 0.60, 95% confidence interval (CI) = 0.38-0.94, P = .02). Falls were more common in the high-dose group (1.47 per person-year vs 0.63 in standard-dose group; IRR = 2.33, 95% CI = 1.49-3.63, P < .001). Fractures were uncommon and similar in both groups (high dose 0.10 vs standard dose 0.19 per person-year; P = .31). Mean trough 25-hydroxyvitamin D levels during the trial were 32. ng/mL in the high-dose group and 25.1 ng/mL in the standard-dose group. There was no hypercalcemia or kidney stones in either group. CONCLUSION: Monthly high-dose vitamin D3 supplementation reduced the incidence of ARI in older long-term care residents but was associated with a higher rate of falls without an increase in fractures.
RCT Entities:
OBJECTIVES: To determine the efficacy and safety of high-dose vitamin D supplementation for prevention of acute respiratory infection (ARI) in older long-term care residents. DESIGN: Randomized controlled trial investigating high-dose vs standard-dose vitamin D from 2010 to 2014. SETTING: Colorado long-term care facilities. PARTICIPANTS: Long-term care residents aged 60 and older (n = 107). INTERVENTION: The high-dose group received monthly supplement of vitamin D3 100,000 IU, the standard-dose group received a monthly placebo (for participants taking 400-1,000 IU/d as part of usual care) or a monthly supplement of 12,000 IU of vitamin D3 (for participants taking <400 IU/d as part of usual care). MEASUREMENTS: The primary outcome was incidence of ARI during the 12-month intervention. Secondary outcomes were falls and fractures, 25-hydroxyvitamin D levels, hypercalcemia, and kidney stones. RESULTS:Participants (55 high dose, 52 standard dose) were randomized and included in the final analysis. The high-dose group had 0.67 ARIs per person-year and the standard-dose group had 1.11 (incidence rate ratio (IRR) = 0.60, 95% confidence interval (CI) = 0.38-0.94, P = .02). Falls were more common in the high-dose group (1.47 per person-year vs 0.63 in standard-dose group; IRR = 2.33, 95% CI = 1.49-3.63, P < .001). Fractures were uncommon and similar in both groups (high dose 0.10 vs standard dose 0.19 per person-year; P = .31). Mean trough 25-hydroxyvitamin D levels during the trial were 32. ng/mL in the high-dose group and 25.1 ng/mL in the standard-dose group. There was no hypercalcemia or kidney stones in either group. CONCLUSION: Monthly high-dose vitamin D3 supplementation reduced the incidence of ARI in older long-term care residents but was associated with a higher rate of falls without an increase in fractures.
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