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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03859687
The ClinicalTrials.gov registry entry for NCT03859687 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vitamin A supplementation is the first listed.
NCT03859687 reports 0 study locations.
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.
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