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NCT03859687 · ClinicalTrials.gov registry record · Phase 1
Trial of Antibody Responses by Vitamin Supplementation
A Phase 1 study, sponsored by St. Jude Children's Research Hospital.
- Terminated
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT03859687: Clinical Trial Phase 1 study, sponsored by St. Jude Children's Research Hospital.
NCT03859687 is a Phase 1 study that was terminated before completion, run by St. Jude Children's Research Hospital. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03859687, a Phase 1 study, was terminated before completion, sponsored by St. Jude Children's Research Hospital.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The seroconversion rate, defined as the proportion of 4X increases or conversion from undetectable to detectable response in vaccine-specific antibody after vaccinations (Day 21) versus the baseline (Day 0) antibody level in intervention and control groups will be estimated and 95% confidence interval will be described for both groups. The 95% confidence interval will serve as a measure of precision of the seroconversion rate estimate. Chi-square test will be performed to make the comparison bet
Interventions
- BIOLOGICAL Vitamin A supplementation
- BIOLOGICAL No vitamin A supplementation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2019-08-19 |
| Est. Completion | 2025-07-10 |
| Phase | Phase 1 |
Why NCT03859687 stopped before completion
NCT03859687 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which Vitamin A supplementation is the first listed.
NCT03859687 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03859687 about?
NCT03859687 is a clinical study titled "Trial of Antibody Responses by Vitamin Supplementation". 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 w...
What is the current status of trial NCT03859687?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2019-08-19. Estimated completion is 2025-07-10.
What interventions are being tested in trial NCT03859687?
The interventions under investigation include: Vitamin A supplementation (BIOLOGICAL), No vitamin A supplementation (BIOLOGICAL).
Who is sponsoring clinical trial NCT03859687?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03859687's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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