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Vitamin A for Vaccine Response Enhancement

Phase 1
Recruiting
Led By Nehali Patel, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Received at least 2 doses of Prevnar-13 vaccination
Between 1 and 4 years old (inclusive) at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at day 21
Awards & highlights

Study Summary

This trial is testing whether giving vitamin A to children along with their pneumococcal and hepatitis A vaccines will improve the vaccine's effectiveness.

Who is the study for?
This trial is for healthy children aged 1-4 who have been weaned off breast/formula feeding for at least 4 weeks and received at least two doses of Prevnar-13 vaccine. They can't join if they've had severe allergic reactions to certain vaccines, are on cancer treatments or immunosuppressive drugs, have a feverish illness close to enrollment, take daily vitamins during the study, or have chronic health conditions.Check my eligibility
What is being tested?
The study tests whether vitamin A supplementation improves the immune response in young children receiving the Prevnar vaccine. It measures changes in antibody levels after taking vitamin A with their vaccine compared to those who don't supplement. The effect on hepatitis vaccine response is also studied.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include typical responses to vitamin supplements such as nausea or headaches and any usual reactions from vaccinations like soreness at injection site or mild fever.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have received at least 2 doses of the Prevnar-13 vaccine.
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I am between 1 and 4 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at day 21
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at day 21 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sera titer ratio
Seroconversion rate in two arms
Secondary outcome measures
Correlation of immunoglobulin A (IgA) antibody(measured by Luminex assay)
Correlation of immunoglobulin G subclass 1 (IgG1) antibody (measured by Luminex assay)
Correlation of immunoglobulin G subclass 2 (IgG2) antibody (measured by Luminex assay
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Intervention groupExperimental Treatment1 Intervention
PCV (Prevnar-13 Vaccine) and the hepatitis A vaccine (Havrix Vaccine) plus a liquid oral vitamin A supplementation
Group II: Control groupExperimental Treatment1 Intervention
PCV (Prevnar-13 Vaccine) and the hepatitis A vaccine (Havrix Vaccine) only, 'No vitamin A supplementation'
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin A supplementation
2017
N/A
~60

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
427 Previous Clinical Trials
5,306,497 Total Patients Enrolled
The Gerber FoundationOTHER
41 Previous Clinical Trials
5,916 Total Patients Enrolled
Nehali Patel, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
1 Previous Clinical Trials
87 Total Patients Enrolled

Media Library

Vitamin A supplementation Clinical Trial Eligibility Overview. Trial Name: NCT03859687 — Phase 1
Healthy Subjects Research Study Groups: Intervention group, Control group
Healthy Subjects Clinical Trial 2023: Vitamin A supplementation Highlights & Side Effects. Trial Name: NCT03859687 — Phase 1
Vitamin A supplementation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03859687 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What ailments are commonly addressed through Vitamin A supplementation?

"Vitamin d deficiency can often be ameliorated with the use of Vitamin A. Additionally, this nutrient may also provide symptomatic relief for conditions like Vitamin A deficiency and nutritional imbalances."

Answered by AI

Can this clinical trial be considered groundbreaking in its approach?

"Currently, 8 trials related to Vitamin A supplementation are ongoing in 10 cities across 2 countries. In 2015, Alkeus Pharmaceuticals sponsored the first ever clinical trial for this supplement. After collecting data from 140 participants and completing Phase 2 drug approval process, 32 additional studies have been conducted since then."

Answered by AI

Are there any remaining openings for prospective participants in this research project?

"Affirmative. Clinicaltrials.gov contains confirmation that this clinical trial is actively seeking participants, with the initial posting date of August 19th 2019 and last update on November 29th 2022. Eighty volunteers are called for to be recruited across one medical facility."

Answered by AI

What are the primary objectives of this research endeavor?

"This trial, measured at Day 21, seeks to evaluate the sera titer ratio. Secondary outcomes include a correlation of IgM antibody (measured by Luminex assay) expressed as Spearman's coefficient and similarly an examination of vaccine antibody responses in relation to baseline vitamin levels for each arm with Spearman's correlation coefficient."

Answered by AI

Is the age range for this research encompassing individuals younger than 60 years old?

"To be enrolled in this medical trial, patients must range from 1 Year to 4 Years old. There are 54 studies available for participants under 18 and 379 trials offered to individuals over 65 years of age."

Answered by AI

Has there been prior research conducted on the efficacy of Vitamin A supplementation?

"At present, 8 medical studies are examining the benefits of Vitamin A supplementation with 2 trials in their final stage. Most of these clinical investigations are located in Somerville, Massachusetts; however there are 13 sites across the country running similar research protocols."

Answered by AI

What is the upper limit of individuals participating in this medical experiment?

"Affirmative. According to clinicaltrials.gov, this medical experiment was initially posted on August 19th 2019 and is currently recruiting participants. The research demands 80 individuals from a single location for this trial."

Answered by AI

Has the FDA sanctioned Vitamin A supplementation?

"Given the preliminary nature of this clinical trial, our team at Power assigned Vitamin A a score of 1 as it has not yet been extensively tested for safety and efficacy."

Answered by AI

May I be considered a participant in this research endeavor?

"This study seeks to enroll 80 participants aged 1-4 years. To be considered, applicants must have been fully weaned for a minimum of 4 weeks prior to vaccination."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Trial of Antibody Responses by Vitamin Supplementation
2019. "Trial of Antibody Responses by Vitamin Supplementation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03859687.
~10 spots leftby Jan 2025
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