Phase 2
N=107
Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents
Respiratory Infection
Bottom Line
View on ClinicalTrials.gov: NCT01102374 ↗Enrolled (actual)
107
Serious AEs
20.6%
Results posted
Apr 2017
Primary outcome: Primary: Number of Acute Respiratory Infections (ARIs) — 32; 48 events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- High Dose Vitamin D (Drug); Standard Dose Vitamin D (Drug); Placebo (Drug); Usual Care (Dietary_supplement)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Acute Respiratory Infections (ARIs) |
32; 48 | — |
| SECONDARY Severity of Acute Respiratory Infections |
3; 6 | — |
| SECONDARY Time to First ARI |
0.59; 1.00 | — |
| SECONDARY Change in 25-hydroxyvitamin D (25OHD) Level |
8.18; 2.71 | — |
| SECONDARY Change in Parathyroid Hormone Level |
— | — |
| SECONDARY Falls |
70; 27 | — |
| SECONDARY Fractures |
5; 8 | — |
| SECONDARY Number of Upper Respiratory Infections |
21; 36 | — |
| SECONDARY Number of Lower Respiratory Infections |
11; 12 | — |
| SECONDARY Number of Influenza-like Illnesses |
— | — |
| SECONDARY Incident Kidney Stones |
0; 0 | — |
| SECONDARY Incident Hypercalcemia |
0; 0 | — |
| SECONDARY Death |
9; 13 | — |
| SECONDARY Number of Urinary Tract Infections |
38; 22 | — |
| SECONDARY Number of Other Infections |
33; 43 | — |
Summary
This 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.
Eligibility Criteria
Inclusion Criteria
- Age 60+ years
- Resides in nursing home
Exclusion Criteria
- Terminal illness (expected survival 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
Data sourced from ClinicalTrials.gov (NCT01102374). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.