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

Not Applicable

Completed

• Conditions: Viral Upper Respiratory Tract Infection
• Interventions: Other: Placebo; Dietary Supplement: Vitamin D3

• Registration Number: NCT00656929
• Lead Sponsor: Winthrop University Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2008-04
• Study First Submitted: 2008-04-07
• Study First Submitted QC: 2008-04-10
• Last Update Submitted: 2008-04-10
• Study First Posted: 2008-04-11
• Last Update Posted: 2008-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo tablets
1	Vitamin D3	Vitamin D3 50 mcg (2000 IU) daily

Primary Outcome Measures

Name	Time	Method
To see whether vitamin D3 supplementation during the winter prevents viral URI.	3 months