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

This study has been completed.
Sponsor:
Information provided by:
Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT00656929
First received: April 7, 2008
Last updated: April 10, 2008
Last verified: April 2008
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Vitamin D3 Supplementation for the Prevention of Viral Upper Respiratory Tract Infections

Resource links provided by NLM:

U.S. FDA Resources

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
Active Comparator: 1
Vitamin D3 50 mcg (2000 IU) daily
 Dietary Supplement: Vitamin D3
Vitamin D3 (cholecalciferol) 50 mcg (2000 IU) daily x 3 months
Other Names:
  • vitamin D3
  • cholecalciferol
Placebo Comparator: 2
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

No publications provided

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

Keywords provided by Winthrop University Hospital:
Vitamin D
Viral URI
Influenza
Colds

Additional relevant MeSH terms:
Respiratory Tract Infections
Common Cold
Infection
Respiratory Tract Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Cholecalciferol
 Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 16, 2013