A Randomized Trial of Vitamin D to Reduce Respiratory Infection

NCT01705314 | Completed

• 1 other identifier: VitD2012
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Infection

Keywords

human influenza children

Outcome Measures

Primary Outcomes (2)

• Laboratory-confirmed non-influenza infection

  12 months

• Laboratory-confirmed influenza infection

  12 months

Study Arms (2)

vitamin D supplements

EXPERIMENTAL

children and adolescents that are randomized to the intervention will receive 7 mls of D-drops (14,000U/week of vitamin D) for eight months

Dietary Supplement: vitamin D supplements

vitamin D placebo

PLACEBO COMPARATOR

children and adolescents that are randomized to placebo will receive 7 mls of placebo drops for eight months

Dietary Supplement: placebo

Interventions

vitamin D supplements DIETARY_SUPPLEMENT

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

vitamin D supplements

placebo DIETARY_SUPPLEMENT

7mls of placebo drops per week for 8 months.

vitamin D placebo

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Between the ages of 3 and 17
• Residing in Thanh Liem District, Ha Nam Province, Vietnam

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

National Institute of Hygiene and Epidemiology

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Mark Loeb, MD

  McMaster University, Hamilton, ON, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: October 12, 2012
• Study Start: December 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)