A Randomized Trial of Vitamin D to Reduce Respiratory Infection

Not Applicable

Completed

• Conditions: Respiratory Infection
• Interventions: Dietary Supplement: vitamin D supplements; Dietary Supplement: placebo

• Registration Number: NCT01705314
• Lead Sponsor: McMaster University

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2012-10-09
• Study First Submitted QC: 2012-10-11
• Study First Posted: 2012-10-12
• Study Start: 2014-12
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1300

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitamin D supplements	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
vitamin D placebo	placebo	children and adolescents that are randomized to placebo will receive 7 mls of placebo drops for eight months

Primary Outcome Measures

Name	Time	Method
Laboratory-confirmed non-influenza infection	12 months
Laboratory-confirmed influenza infection	12 months

Trial Locations

Locations (1)

National Institute of Hygiene and Epidemiology; 🇻🇳 Hanoi, Vietnam