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

Primary Purpose

Viral Upper Respiratory Tract Infection

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
Winthrop University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Viral Upper Respiratory Tract Infection focused on measuring Vitamin D, Viral URI, Influenza, Colds

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Vitamin D3 50 mcg (2000 IU) daily

    Placebo tablets

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    April 7, 2008
    Last Updated
    April 10, 2008
    Sponsor
    Winthrop University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00656929
    Brief Title
    Randomized Controlled Trial of Vitamin D3 Supplementation for Viral Upper Respiratory Tract Infections (URI) Prevention
    Official Title
    A Randomized Controlled Trial of Vitamin D3 Supplementation for the Prevention of Viral Upper Respiratory Tract Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2006 (undefined)
    Primary Completion Date
    June 2007 (Actual)
    Study Completion Date
    June 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Winthrop University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Viral Upper Respiratory Tract Infection
    Keywords
    Vitamin D, Viral URI, Influenza, Colds

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    167 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Vitamin D3 50 mcg (2000 IU) daily
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo tablets
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Vitamin D3
    Other Intervention Name(s)
    cholecalciferol
    Intervention Description
    Vitamin D3 (cholecalciferol) 50 mcg (2000 IU) daily x 3 months
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo tablets
    Primary Outcome Measure Information:
    Title
    To see whether vitamin D3 supplementation during the winter prevents viral URI.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John F Aloia, MD
    Organizational Affiliation
    Winthrop University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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