Overview

This trial is active, not recruiting.

Conditions vitamin d, respiratory infection
Treatments high dose vitamin d, standard dose vitamin d
Phase phase 2
Sponsor University of Colorado, Denver
Collaborator National Institute on Aging (NIA)
Start date May 2010
End date August 2014
Trial size 200 participants
Trial identifier NCT01102374, 09-0899, IND 106541

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
high dose vitamin d
Vitamin D3 100,000 IU monthly
(Active Comparator)
standard dose vitamin d
Vitamin D 400-1000 IU per day

Primary Outcomes

Measure
Number of acute respiratory infections (ARIs)
time frame: 12 months

Secondary Outcomes

Measure
Severity of acute respiratory infections
time frame: 12 month
Time to first ARI
time frame: 12 months
Change in 25-hydroxyvitamin D (25OHD) level
time frame: 12 months
Change in parathyroid hormone level
time frame: 12 months
Falls
time frame: 12 months
Fractures
time frame: 12 months
Number of upper respiratory infections
time frame: 12 months
Number of lower respiratory infections
time frame: 12 months
Number of influenza-like illnesses
time frame: 12 months
Incident kidney stones
time frame: 12 months
Incident hypercalcemia
time frame: 12 months
Death
time frame: 12 months
Number of urinary tract infections
time frame: 12 months
Number of other infections
time frame: 12 months

Eligibility Criteria

Male or female participants at least 60 years old.

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

Additional Information

Official title Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents
Principal investigator Adit A Ginde, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.