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A Randomized Trial of Vitamin D to Reduce Respiratory Infection

NCT ID: NCT01705314

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Infection

Keywords

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human influenza children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

vitamin D supplements

Intervention Type DIETARY_SUPPLEMENT

Participants will receive 7mls of D-drops (14,000U/week of vitamin D)

vitamin D placebo

children and adolescents that are randomized to placebo will receive 7 mls of placebo drops for eight months

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

7mls of placebo drops per week for 8 months.

Interventions

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vitamin D supplements

Participants will receive 7mls of D-drops (14,000U/week of vitamin D)

Intervention Type DIETARY_SUPPLEMENT

placebo

7mls of placebo drops per week for 8 months.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Loeb, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University, Hamilton, ON, Canada

Locations

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National Institute of Hygiene and Epidemiology

Hanoi, , Vietnam

Site Status

Countries

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Vietnam

Other Identifiers

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VitD2012

Identifier Type: -

Identifier Source: org_study_id