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Trial record 37 of 40 for:    Citrus reticulata

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

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ClinicalTrials.gov Identifier: NCT02649192
Recruitment Status : Completed
First Posted : January 7, 2016
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Healthy Participants Biological: Influenza virus vaccine Dietary Supplement: Vitamins A and D Other: Placebo Phase 2

Detailed Description:

Participants will be randomized to receive either an influenza virus vaccine plus Vitamins A & D or an influenza virus vaccine plus placebo. They will be stratified based on retinol binding protein (RBP) levels at screening, using a cut-off indicative of Vitamin A insufficiency (≤22,000 ng/ml). Co-enrolled sibling participants will be first stratified by RBP levels, then siblings within the same stratum will be equally assigned to different arms to provide greater assurance of balanced treatment assignment. 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 antibody immune response.

All participants will receive two doses of an influenza virus vaccination administered at least 28 days apart. Vitamin levels and antibody responses toward the vaccine will be measured on day 0 (baseline levels obtained where day 0 equals the first influenza virus vaccination administration), day 28, and day 56. Placebo or Vitamins A + D (at the levels of 20,000 IU and 2,000 IU, respectively) will be administered orally on the days of vaccination.

Blood serum samples will be collected from participants on Day 0, prior to receiving influenza virus vaccine on Day 28, and during their Day 56 follow-up visit.

Parents will be asked to fill out diary cards to indicate food intake for children during the study period along with an optional food frequency questionnaire given on day 56. Specific measurements on days 28, and 56 will include analyses of vaccine-specific and total IgA, IgG, and IgA/IgG plus IgA/IgM ratios in sera. Functional activities of antibodies toward influenza vaccine will also be measured.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double-Blind, Randomized, Placebo-Controlled Study of Antibody Induction by Vitamin Supplementation at the Time of Influenza Virus Vaccinations in Children
Actual Study Start Date : January 21, 2016
Actual Primary Completion Date : June 29, 2018
Actual Study Completion Date : June 29, 2018


Arm Intervention/treatment
Active Comparator: Influenza Virus Vaccine Plus Vitamins A and D
Participants receive influenza virus vaccine and Vitamins A and D supplement on Day 0 and Day 28.
Biological: Influenza virus vaccine
Children will have the first influenza virus vaccine dose (dose 1) administered on day 0 of the trial, and the second dose (dose 2) administered 28 days later.
Other Name: Fluzone®

Dietary Supplement: Vitamins A and D
The chewable gummy contains either Vitamin A (20,000 International Units) and Vitamin D3 (2,000 International Units), which should be fully chewed under supervision of study staff with documentation in the participant's research record and eMAR (electronic medical administration record). The chewable gummy should be administered prior to receiving influenza virus vaccination.
Other Name: Nutritional Supplement

Placebo Comparator: Influenza Virus Vaccine Plus Placebo
Participants receive influenza virus vaccine and matched placebo on Day 0 and Day 28.
Biological: Influenza virus vaccine
Children will have the first influenza virus vaccine dose (dose 1) administered on day 0 of the trial, and the second dose (dose 2) administered 28 days later.
Other Name: Fluzone®

Other: Placebo
The chewable gummy matched placebo will be formulated with gelatin base and tangerine oil and match the Vitamin A and D in shape, taste, texture, and appearance. Gummies should be fully chewed under supervision of study staff with documentation in the participant's research record and eMAR (electronic medical administration record). The chewable gummy should be administered prior to receiving influenza virus vaccination.
Other Names:
  • Look-alike Medication
  • Matched Placebo




Primary Outcome Measures :
  1. Proportion of positive responses in virus-specific antibody in sera [ Time Frame: Day 56 after first vaccination ]

    The proportion of 2X increases or conversion from undetectable to detectable response in virus-specific antibody after 2 immunizations in intervention and control groups will be reported.

    The point estimate and 95% confidence interval will be estimated for both groups, overall and by stratum. The proportion difference with 95% confidence interval will be reported, overall and by stratum. Due to possible variation in virus strains and influenza virus vaccine formula in different flu seasons, analyses by season will also be described. Continuous titer values in both groups, overall or by stratum, will be described and compared with point estimate along with 95% confidence intervals.


  2. Sera titer ratio [ Time Frame: Day 56 after first vaccination ]
    Titer ratios will be summarized with descriptive statistics. Two-sample tests (t-test or Wilcoxon rank-sum test) will be applied whenever appropriate.


Secondary Outcome Measures :
  1. Sero-conversion rate [ Time Frame: Day 56 after first vaccination ]
    Secondary analyses will examine sero-conversion based on antibody functions (HAI or neutralization) defined as antibody titers of <1:40 converting to ≥1:40, or a four-fold increase in titer for participants with a starting titer of ≥1:40. Sero-conversion rate will be estimated with proportion and 95% confidence interval for both groups, overall and by stratum. The rate difference will be described with point estimate and 95% confidence interval, overall and by stratum. Due to possible variation in virus strains and influenza virus vaccine formula in different flu seasons, analyses by season will also be described. Continuous titer values in both groups, overall or by stratum, will also be described and compared with point estimate along with 95% confidence intervals.



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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Resident of the Memphis area community.
  • Parent or legal guardian willing and able to give informed consent and comply with study requirements.

Exclusion Criteria:

  • Current use of investigational or immunosuppressive drugs (e.g., steroids) at the time of enrollment.
  • Currently taking a daily (routine) vitamin A, D, or multivitamin. Note: participants who report occasional or sporadic vitamin use will be allowed to enroll.
  • History of lung disease, asthma, immunodeficiency, sickle cell disease, or any other serious underlying condition or disease in the opinion of the principal investigator.
  • Evidence of developmental delay or evolving neurological disorders at screening. Current use of antibiotics or antivirals at enrollment.
  • History of having a severe allergy to eggs or to any inactive ingredient in the influenza virus vaccine
  • History of a life-threatening reaction to influenza vaccinations
  • Currently wheezing at the time of enrollment
  • History of heart, kidney, or lung conditions
  • History of diabetes
  • Use of an anti-influenza medication (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to enrollment
  • Acute febrile [>100.0°F (37.8°C) oral] illness or acute respiratory illness (e.g., cough or sore throat) within 3 days prior to enrollment
  • Previous receipt of current seasonal influenza vaccine

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): NCT02649192


Locations
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United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
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Principal Investigator: Nehali Patel, MD St. Jude Children's Research Hospital

Additional Information:
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Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT02649192     History of Changes
Other Study ID Numbers: FLUVIT
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Jude Children's Research Hospital:
Children
Vitamin Supplements
Influenza virus vaccine

Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Vitamins
Vitamin A
Vitamin D
Retinol palmitate
Immunologic Factors
Physiological Effects of Drugs
Micronutrients
Nutrients
Growth Substances
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Bone Density Conservation Agents