Trial of Antibody Responses by Vitamin Supplementation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-19

Study Completion Date

2025-07-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Streptococcus pneumoniae, commonly called pneumococcus, can cause a wide range of diseases in children from mild ear infections to deadly pneumonia or meningitis. Vaccination is currently the single best way to protect children. Nutrition, especially the amount of vitamin A, may play a role in how well your body responds to infection or a vaccine. We call this an immune response. This research will look to see if children who take a vitamin with their vaccine have a better immune response than children who do not take a vitamin with their vaccine.

Primary Objective

To evaluate the influence of vitamin A supplementation on Prevnar vaccine immunogenicity based on changes in antibody scores in a commercial ELISA at Day 21 (after a booster vaccine dose) compared to pre-vaccine values.

Secondary Objectives

* To evaluate the relationship between baseline vitamin levels and pneumococcal or hepatitis A vaccine antibody responses (based on in commercial ELISAs) at Days 0 and 21.
* To evaluate the influence of vitamin A supplementation on hepatitis vaccine immunogenicity based on changes in antibody scores in a commercial ELISA at Day 21 compared to pre-vaccine values.
* To evaluate relationships between total serum antibodies (based on individual IgM, IgG1, IgG2, IgG3, IgG4, and IgA scores in a Luminex assay) at Day 0 and changes between Days 0 and 21 with baseline (Day 0) vitamin levels in young children, and with vitamin A supplementation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Vitamin A Supplementation on Immune Responses in Human Neonates

NCT01476358

Vitamin A Deficiency

UNKNOWN PHASE2

Using Stable Isotopes to Assess the Effectiveness of Vitamin A Supplementation in Cameroon

NCT03383744

Vitamin A Deficiency

COMPLETED NA

Evaluation of Vitamin A and Zinc Supplementation on Malarial Morbidity

NCT01782001

Malaria Malnutrition

COMPLETED PHASE3

Vitamin A Supplementation in Children With Moderate to Severe COVID-19

NCT04920760

Covid19

UNKNOWN PHASE2

The Effect of Adjunct Vitamin a on Community-Acquired Pneumonia in Southern Iranian Children: a Randomized Clinical Trial

NCT06677684

Community-Acquired Pneumonia Vitamin a

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Children between the ages of 1 and 4 years old (inclusive) will be enrolled. All will receive PCV and hepatitis A vaccination. Those randomized to the treatment arm will receive 10,000 IU orally at the time of vaccination, while those randomized to the control arm will only receive vaccines. Vitamin levels and antibody responses towards the vaccines will be measured at screening, Day 0 (vaccination day) and Day +21. Children will be randomized using a stratified permuted block method.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Participants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

PCV (Prevnar-13 Vaccine) and the hepatitis A vaccine (Havrix Vaccine) plus a liquid oral vitamin A supplementation

Group Type EXPERIMENTAL

Vitamin A supplementation

Intervention Type BIOLOGICAL

liquid oral vitamin A supplementation

Control group

PCV (Prevnar-13 Vaccine) and the hepatitis A vaccine (Havrix Vaccine) only, 'No vitamin A supplementation'

Group Type EXPERIMENTAL

No vitamin A supplementation

Intervention Type BIOLOGICAL

No vitamin A supplementation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin A supplementation

liquid oral vitamin A supplementation

Intervention Type BIOLOGICAL

No vitamin A supplementation

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Between 1 and 4 years old (inclusive) at the time of enrollment
* Fully weaned from breast-feeding or formula-feeding for at least 4 weeks prior to vaccination date (Day 0).
* Received at least 2 doses of Prevnar-13 vaccination
* Parent or legal guardian willing and able to provide informed consent.

Exclusion Criteria

* Current use of investigational or immunosuppressive drugs (e.g., steroids) at the time of enrollment
* Parent/guardian planning to continue (or initiate) the administration of daily vitamin A, vitamin D, or multivitamin to the child during the study period.
* Evidence of developmental delay or evolving neurological disorders at screening.
* Current use of antibiotics or antivirals at enrollment.
* Currently receiving cancer related treatment.
* History of heart, kidney, or chronic respiratory condition (e.g., asthma) conditions.
* History of diabetes.
* Acute febrile illness \[e.g., \>100.0F (37.8oC) oral\] illness within 3 days prior to enrollment.
* Received a previous PCV13 vaccine within 2 months of the enrollment date (Day 0).
* Received hepatitis A vaccine previously.
* Ever had a life-threatening allergic reaction to a dose of PCV13 vaccine, to an earlier pneumococcal vaccine called PCV7, or to any vaccine containing diptheria toxoid (for example, DTaP).

Minimum Eligible Age

1 Year

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes