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A Randomized Trial of Vitamin D to Reduce Respiratory Infection

NCT01705314 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2016-10-26

No results posted yet for this study

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.

Conditions

  • Respiratory Infection

Interventions

DIETARY_SUPPLEMENT

vitamin D supplements

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

DIETARY_SUPPLEMENT

placebo

7mls of placebo drops per week for 8 months.

Sponsors & Collaborators

Principal Investigators

  • Mark Loeb, MD · McMaster University, Hamilton, ON, Canada

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Vietnam

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01705314 on ClinicalTrials.gov