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

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

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Key information

Conditions

Viral Upper Respiratory Tract Infection Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D3

Dietary Supplement

Vitamin D3 (cholecalciferol) 50 mcg (2000 IU) daily x 3 months

Other names: cholecalciferol

Placebo

Other

Placebo tablets

Primary outcomes

To see whether vitamin D3 supplementation during the winter prevents viral URI.

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Winthrop University Hospital

Other

Registry information

Official study title

A Randomized Controlled Trial of Vitamin D3 Supplementation for the Prevention of Viral Upper Respiratory Tract Infections

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Apr 11, 2008
Registry last updated: Apr 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed