A Randomized Trial of Vitamin D to Reduce Respiratory Infection

October 24, 2016 updated by: McMaster University

Effect of Vitamin D3 Supplementation to Reduce Respiratory Infections in Children and Adolescents in Vietnam: A Blinded, Placebo-controlled Randomized Controlled Trial

The goal of this study is to assess the effectiveness of vitamin D in reducing laboratory-confirmed influenza and in reducing non-influenza viral respiratory tract infections. A cohort of children between the ages of 3 and 17 years from the Thanh Ha Commune, Thanh Liem District, Ha Nam Province, Vietnam will be randomized to either weekly vitamin D supplements or placebo. Participants who develop acute respiratory infection over a 12-month period, will be tested for influenza, the co-primary outcome, and other respiratory viruses, the other co-primary outcome, by RT-PCR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam
        • National Institute of Hygiene and Epidemiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between the ages of 3 and 17
  • Residing in Thanh Liem District, Ha Nam Province, Vietnam

Exclusion Criteria:

  • Born prematurely at less than 32 weeks gestation
  • Any chronic illness (except asthma)
  • Currently using medication known to interfere with vitamin D metabolism
  • Children with a sibling participating in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vitamin D supplements
children and adolescents that are randomized to the intervention will receive 7 mls of D-drops (14,000U/week of vitamin D) for eight months
Dietary supplement: vitamin D supplements
Participants will receive 7mls of D-drops (14,000U/week of vitamin D)
Placebo Comparator: vitamin D placebo
children and adolescents that are randomized to placebo will receive 7 mls of placebo drops for eight months
Dietary supplement: placebo
7mls of placebo drops per week for 8 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Laboratory-confirmed non-influenza infection
Time Frame: 12 months
12 months
Laboratory-confirmed influenza infection
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Investigators

  • Principal Investigator: Mark Loeb, MD, McMaster University, Hamilton, ON, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

October 9, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 12, 2012

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VitD2012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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