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A Randomized Trial of Vitamin D to Reduce Respiratory Infection

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ClinicalTrials.gov Identifier: NCT01705314
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Respiratory Infection Dietary Supplement: vitamin D supplements Dietary Supplement: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Effect of Vitamin D3 Supplementation to Reduce Respiratory Infections in Children and Adolescents in Vietnam: A Blinded, Placebo-controlled Randomized Controlled Trial
Study Start Date : December 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: vitamin D supplements
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
Participants will receive 7mls of D-drops (14,000U/week of vitamin D)

Placebo Comparator: vitamin D placebo
children and adolescents that are randomized to placebo will receive 7 mls of placebo drops for eight months
Dietary Supplement: placebo
7mls of placebo drops per week for 8 months.




Primary Outcome Measures :
  1. Laboratory-confirmed non-influenza infection [ Time Frame: 12 months ]
  2. Laboratory-confirmed influenza infection [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705314


Locations
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Vietnam
National Institute of Hygiene and Epidemiology
Hanoi, Vietnam
Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Mark Loeb, MD McMaster University, Hamilton, ON, Canada

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01705314     History of Changes
Other Study ID Numbers: VitD2012
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by McMaster University:
human influenza children
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents