Randomized Controlled Trial of Vitamin D3 Supplementation for Viral Upper Respiratory Tract Infections (URI) Prevention - Full Text View

Sponsored by:	Winthrop University Hospital
Information provided by:	Winthrop University Hospital
ClinicalTrials.gov Identifier:	NCT00656929

Purpose

Background: Vitamin D has been shown to be an important immune system regulator. Vitamin D insufficiency during the winter may cause increased susceptibility to infections, particularly viral upper respiratory tract infections (URIs).

Objective: To determine whether vitamin D supplementation during the winter season prevents or decreases URI symptoms in adults.

Methods: A randomized, double-blind, placebo-controlled trial was conducted in 162 adults. Participants were randomized to receive vitamin D3 50 mcg (2000 IU) daily or matching placebo for 12 weeks from December 2006 to March 2007. A biweekly questionnaire was used to record the incidence and severity of URI symptoms

Condition	Intervention
Viral Upper Respiratory Tract Infection	Dietary Supplement: Vitamin D3 Other: Placebo

Drug Information available for: Vitamin D Ergocalciferol Cholecalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Controlled Trial of Vitamin D3 Supplementation for the Prevention of Viral Upper Respiratory Tract Infections

Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:

To see whether vitamin D3 supplementation during the winter prevents viral URI. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment:	167
Study Start Date:	December 2006
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Vitamin D3 50 mcg (2000 IU) daily	Dietary Supplement: Vitamin D3 Vitamin D3 (cholecalciferol) 50 mcg (2000 IU) daily x 3 months
2: Placebo Comparator Placebo tablets	Other: Placebo Placebo tablets

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

ambulatory adult age 18-80 and stable medical condition with no change in medications for 6 months prior to study entry.

Exclusion Criteria:

morbid obesity (body mass index > 35 kg/m2)
current tobacco use
history of hypercalcemia, nephrolithiasis or sarcoidosis
pregnancy
recent hospitalization
current liver or kidney disorders, malignancy and malabsorption
use of immunosuppressants or medications that interfere with vitamin D metabolism such as phenytoin and carbamazepine.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656929

Sponsors and Collaborators

Winthrop University Hospital

Investigators

Principal Investigator:

John F Aloia, MD

Winthrop University Hospital

More Information

Responsible Party:	Winthrop University Hospital ( John F. Aloia, M.D. )
Study ID Numbers:	WUH06034
Study First Received:	April 7, 2008
Last Updated:	April 10, 2008
ClinicalTrials.gov Identifier:	NCT00656929
Health Authority:	United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:

Vitamin D
Viral URI
Influenza
Colds

Study placed in the following topic categories:

Cholecalciferol
Vitamin D
Respiratory Tract Diseases

Respiratory Tract Infections
Ergocalciferols
Influenza, Human

Additional relevant MeSH terms:

Communicable Diseases
Growth Substances
Vitamins
Physiological Effects of Drugs

Bone Density Conservation Agents
Micronutrients
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009