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Vitamin a booster for Kids' vaccines? small study cut short

NCT ID NCT03859687

Knowledge-focused Sponsor: St. Jude Children's Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This early-phase study looked at whether giving vitamin A along with the pneumococcus vaccine (Prevnar) helps children ages 1 to 4 build a stronger immune response. Only 22 healthy kids were enrolled before the study was stopped early. Researchers measured antibody levels in the blood before and after vaccination to compare those who got vitamin A with those who did not.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vitamin A supplementation
What this could lead to
If it worked, this could point toward a simple way to improve vaccine protection in children.
What could go wrong
The study was terminated early and very small (22 children), so results are limited and may not be reliable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

22 people

The number who actually took part.

Started

Aug 2019

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 4 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

hepatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy participants

Contacts and locations

Locations

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.