Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents

Respiratory Infection Clinical Trial

Official title:

Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102374
• Other study ID #: 09-0899
• Secondary ID: IND 106541K23AG0
• Status: Completed
• Phase: Phase 2
• First received: April 11, 2010
• Last updated: April 18, 2017
• Start date: May 2010
• Est. completion date: July 2016

Study information

• Verified date: April 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: July 2016
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Infection
• Respiratory Tract Infections

Intervention

Drug:
• High Dose Vitamin D
Vitamin D3 100,000 IU monthly
• Standard Dose Vitamin D
Vitamin D 12,000 IU monthly
• Placebo
Placebo monthly

Dietary Supplement:
• Usual Care
Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute on Aging (NIA), The American Geriatrics Society

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):4 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Acute Respiratory Infections (ARIs)	ARIs defined as upper or lower respiratory infections	12 months
Secondary	Severity of Acute Respiratory Infections	ARIs resulting in emergency department visits or hospitalizations	12 month
Secondary	Time to First ARI		12 months
Secondary	Change in 25-hydroxyvitamin D (25OHD) Level		Baseline and 12 months
Secondary	Change in Parathyroid Hormone Level		Baseline and 12 months
Secondary	Falls		12 months
Secondary	Fractures		12 months
Secondary	Number of Upper Respiratory Infections		12 months
Secondary	Number of Lower Respiratory Infections		12 months
Secondary	Number of Influenza-like Illnesses		12 months
Secondary	Incident Kidney Stones		12 months
Secondary	Incident Hypercalcemia		12 months
Secondary	Death		12 months
Secondary	Number of Urinary Tract Infections		12 months
Secondary	Number of Other Infections		12 months