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Vitamin A for Vaccine Response Enhancement
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- I have a history of heart, kidney, or chronic respiratory issues like asthma.I am currently undergoing treatment for cancer.I have received at least 2 doses of the Prevnar-13 vaccine.I plan to give my child daily vitamins during the study.I have a history of diabetes.You had a severe allergic reaction to a vaccine called PCV13, PCV7, or any vaccine with diptheria toxoid (like DTaP) that put your life in danger.I am not taking any experimental drugs or immunosuppressants.I have received the hepatitis A vaccine.You show signs of delayed development or ongoing neurological problems during the screening process.I have not had a fever over 100.0F in the last 3 days.I am currently taking antibiotics or antivirals.I am between 1 and 4 years old.I received the PCV13 vaccine less than 2 months ago.
- Group 1: Intervention group
- Group 2: Control group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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."
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."
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