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

Viral Upper Respiratory Tract Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656929
• Other study ID #: WUH06034
• Status: Completed
• Phase: N/A
• First received: April 7, 2008
• Last updated: April 10, 2008
• Start date: December 2006
• Est. completion date: June 2007

Study information

• Verified date: April 2008
• Source: Winthrop University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Common Cold
• Infection
• Respiratory Tract Infections
• Viral Upper Respiratory Tract Infection

Intervention

Dietary Supplement:
• Vitamin D3
Vitamin D3 (cholecalciferol) 50 mcg (2000 IU) daily x 3 months

Other:
• Placebo
Placebo tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Winthrop University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To see whether vitamin D3 supplementation during the winter prevents viral URI.		3 months	No