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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:
ClinicalTrials.gov Identifier:
NCT00656929
First Posted: April 11, 2008
Last Update Posted: April 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Winthrop University Hospital
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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 ]

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 Name: cholecalciferol
Placebo Comparator: 2
Placebo tablets
Other: Placebo
Placebo tablets

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656929


Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: John F Aloia, MD Winthrop University Hospital
  More Information

Responsible Party: John F. Aloia, M.D., Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT00656929     History of Changes
Other Study ID Numbers: WUH06034
First Submitted: April 7, 2008
First Posted: April 11, 2008
Last Update Posted: April 11, 2008
Last Verified: April 2008

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

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