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A Randomized Trial of Vitamin D to Reduce Respiratory Infection

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01705314
Enrollment
1300
Registered
2012-10-12
Start date
2014-12-31
Completion date
2016-05-31
Last updated
2016-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Infection

Keywords

human influenza children

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.

Interventions

DIETARY_SUPPLEMENTvitamin D supplements

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

DIETARY_SUPPLEMENTplacebo

7mls of placebo drops per week for 8 months.

Sponsors

McMaster University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Laboratory-confirmed non-influenza infection12 months
Laboratory-confirmed influenza infection12 months

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026