Clinical trial NCT01102374: Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents
Official title: Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Infection
Keywords: Vitamin D Deficiency
Respiratory Infection
Nursing Home Residents
Geriatrics
Immunosenescence
Prevention
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: The American Geriatrics Society
First posted: 2010-04-13
Enrollment: 107
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Acute Respiratory Infections (ARIs)
timeFrame: 12 months
Secondary outcomes:
measure: Severity of Acute Respiratory Infections
timeFrame: 12 month
measure: Time to First ARI
timeFrame: 12 months
measure: Change in 25-hydroxyvitamin D (25OHD) Level
timeFrame: Baseline and 12 months
measure: Change in Parathyroid Hormone Level
timeFrame: Baseline and 12 months
measure: Falls
timeFrame: 12 months
measure: Fractures
timeFrame: 12 months
measure: Number of Upper Respiratory Infections
timeFrame: 12 months
measure: Number of Lower Respiratory Infections
timeFrame: 12 months
measure: Number of Influenza-like Illnesses
timeFrame: 12 months
measure: Incident Kidney Stones
timeFrame: 12 months
measure: Incident Hypercalcemia
timeFrame: 12 months
measure: Death
timeFrame: 12 months
measure: Number of Urinary Tract Infections
timeFrame: 12 months
measure: Number of Other Infections
timeFrame: 12 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Adit A Ginde, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ginde AA, Blatchford P, Breese K, Zarrabi L, Linnebur SA, Wallace JI, Schwartz RS. High-Dose Monthly Vitamin D for Prevention of Acute Respiratory Infection in Older Long-Term Care Residents: A Randomized Clinical Trial. J Am Geriatr Soc. 2017 Mar;65(3):496-503. doi: 10.1111/jgs.14679. Epub 2016 Nov 16.