Official Title
Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents
Phase
Phase 2Lead Sponsor
University of Colorado, DenverStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Respiratory InfectionIntervention/Treatment
vitamin d3 ...Study Participants
107This study will test the role of high dose vitamin D supplementation in prevention of acute respiratory infection in older nursing home residents. The investigators hypothesize that residents on high dose vitamin D supplementation will have a lower incidence of acute respiratory infection that those on standard dose vitamin D supplementation.
This study is a double-blinded, parallel group, randomized controlled phase II trial of oral high vs. standard dose vitamin D3 supplementation administered monthly for 12 months.
Vitamin D3 100,000 IU monthly
Vitamin D 12,000 IU monthly
Placebo monthly
Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Inclusion Criteria: Age 60+ years Resides in nursing home Exclusion Criteria: Terminal illness (expected survival <6 months) Anticipated discharge within 12 months Unable to take whole or crushed tablets Active cancer, except squamous/basal cell carcinoma Severe malnutrition (body mass index <18 kg/m2) Current immunosuppressive medications (including corticosteroids) Renal failure (estimated glomerular filtration rate < 15 mL/min/1.73m2) Currently taking >1,000 IU/d vitamin D supplementation History (or strong family history) of kidney stones History of sarcoidosis or other granulomatous disorders associated with hypercalcemia Elevated baseline hypercalcemia (albumin-adjusted serum calcium >10.5 mg/dL) Baseline serum 25OHD level ≥ 100 nmol/L Inability to provide informed consent and no available healthcare legally authorized representative Inability of participant or legally authorized representative to speak/understand English
| Event Type | Organ System | Event Term | High Dose Vitamin D | Standard Dose Vitamin D |
|---|
ARIs defined as upper or lower respiratory infections
ARIs resulting in emergency department visits or hospitalizations
