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

NCT00656929 | Completed

• 1 other identifier: WUH06034
• Study Type: interventional
• Target: 167
• Locations: 0 countries
• Sites: N/A

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

Conditions

Viral Upper Respiratory Tract Infection

Keywords

Vitamin D; Viral URI; Influenza; Colds

Outcome Measures

Primary Outcomes (1)

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

  3 months

Study Arms (2)

1

ACTIVE COMPARATOR

Vitamin D3 50 mcg (2000 IU) daily

Dietary Supplement: Vitamin D3

2

PLACEBO COMPARATOR

Placebo tablets

Other: Placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

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

Also known as: cholecalciferol

1

Placebo OTHER

Placebo tablets

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Winthrop University Hospital: lead

MeSH Terms

Conditions

Influenza, Human

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• John F Aloia, MD

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 7, 2008
• First Posted: April 11, 2008
• Study Start: December 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: April 11, 2008

Record last verified: 2008-04