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Completed Phase 2 Interventional Accepts healthy volunteers Results available

Influenza Virus Vaccine Plus Vitamin A and D Supplements for Prevention of Respiratory Virus Infections in Children

ClinicalTrials.gov ID: NCT02649192

Public ClinicalTrials.gov record NCT02649192. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 8:00 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double-Blind, Randomized, Placebo-Controlled Study of Antibody Induction by Vitamin Supplementation at the Time of Influenza Virus Vaccinations in Children

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Children are particularly vulnerable to respiratory virus infections, especially influenza. Vitamin A \& D deficiencies are associated with vulnerability to infectious diseases of the respiratory tract. The central hypothesis of this protocol is that vitamin supplements will enhance antibody responses toward the flu vaccine in children. Children, 2-8 years old, will be randomized to receive influenza virus vaccine with a vitamin A+D supplement or influenza virus vaccine with placebo. Children will be tested for vitamin levels and immune responses before and after influenza virus vaccinations to determine if vitamin supplementation improves the influenza virus vaccine-induced immune response. PRIMARY OBJECTIVE: * To assess the vaccine-induced and total antibody (including IgG and IgA) response after influenza virus vaccine administration and IgA/IgG plus IgA/IgM ratios at 28 and 56 days in sera SECONDARY OBJECTIVE: * To assess the neutralizing response toward influenza virus vaccine in the sera.

Study identification

NCT ID
NCT02649192
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
87 participants

Conditions and interventions

Interventions

Biological · Dietary Supplement · Other

Eligibility (public fields only)

Age range
2 Years to 8 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 20, 2016
Primary completion
Jun 28, 2018
Completion
Jun 28, 2018
Last update posted
Oct 28, 2019

2016 – 2018

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
St. Jude Children's Research Hospital Memphis Tennessee 38105

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02649192, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 28, 2019 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02649192 live on ClinicalTrials.gov.

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