A Randomized Trial of Vitamin D to Reduce Respiratory Infection

Respiratory Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01705314
• Other study ID #: VitD2012
• Status: Completed
• Phase: N/A
• First received: October 9, 2012
• Last updated: October 24, 2016
• Start date: December 2014
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Infection
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• vitamin D supplements
Participants will receive 7mls of D-drops (14,000U/week of vitamin D)
• placebo
7mls of placebo drops per week for 8 months.

Locations

Country	Name	City	State
Vietnam	National Institute of Hygiene and Epidemiology	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laboratory-confirmed non-influenza infection		12 months	No
Primary	Laboratory-confirmed influenza infection		12 months	No