A Randomized Trial of Vitamin D to Reduce Respiratory Infection

McMaster University1,300 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

1,300

Conditions

Respiratory Infection

Interventions

vitamin D supplementsDIETARY_SUPPLEMENT

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

placeboDIETARY_SUPPLEMENT

7mls of placebo drops per week for 8 months.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

National Institute of Hygiene and Epidemiology

Hanoi, Vietnam

Outcomes

Primary Outcomes

Laboratory-confirmed non-influenza infection

Time frame: 12 months

Laboratory-confirmed influenza infection

Time frame: 12 months

Data from ClinicalTrials.gov

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