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Completed

NCT Number: NCT01705314

A Randomized Trial of Vitamin D to Reduce Respiratory Infection

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.

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Key information

Conditions

Respiratory Infection Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Hygiene and Epidemiology

Hanoi, Vietnam

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vitamin D supplements

Dietary Supplement

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

Placebo

Dietary Supplement

7mls of placebo drops per week for 8 months.

Primary outcomes

  1. Laboratory-confirmed non-influenza infection

    Time frame: 12 months

  2. Laboratory-confirmed influenza infection

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 12, 2012
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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