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Vitamin A Supplementation for Age-Related Macular Degeneration
Study Summary
This trial is studying vitamin A as a possible treatment for age-related macular degeneration. Researchers want to see if taking 16,000 IU of vitamin A per day improves vision in people with AMD.
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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Who is running the clinical trial?
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- I am 50 years old or older.I use barrier methods with spermicide or am surgically sterilized.You have an intrauterine device (IUD) in place.I have advanced macular degeneration with severe eye damage.I have an eye condition that could change my vision during the study.I have a severe cataract that significantly affects my vision.I am taking vitamin A palmitate supplements of 8,000 IU or more.I am currently participating in another research study and receiving treatment.I have had a vitamin A deficiency in the past.I have had hepatitis or liver failure in the past.I have a long-term stomach or intestine condition.I haven't had major eye surgery in the last 3 months.I had a YAG laser eye procedure within the last two months.I am 50 years old or older.I agree not to take more than 8000 IU of vitamin A palmitate outside the study.My liver function is normal or has only mild issues.You must agree to notify the study investigator or coordinator if any of your doctors initiate a new prescription medication during the course of this study.
- Group 1: Participants
- 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 therapeutic purpose does Vitamin A palmitate serve?
"Vitamin A palmitate is a reliable remedy for ailments associated with Vitamin d and A scarcity."
Could you discuss any other research that has been conducted related to Vitamin A palmitate?
"Vitamin A palmitate is the subject of 8 active trials, 2 of which are in their final stage. The research into this vitamin is taking place across 13 sites; with a notable concentration located in Somerville, Massachusetts."
What are the desired outcomes of this research endeavor?
"The primary assessment of this clinical trial, spanning Baseline and Two months is the quantification of dark adaptation parameters (thresholds and kinetics) for Cohort 2. Secondary objectives entail alterations in LLVA and LLQ - as measured by changes to both LLVA & patient reported outcomes via the LLQ - for Cohorts 1 & 2 respectively."
How many participants are involved with this research endeavor?
"Affirmative, information on clinicaltrials.gov implies that this study is accepting participants at the moment. It was initially listed on April 20th 2018 and has been updated recently in November 8th 2022. The trial necessitates procuring a total of 20 individuals from 1 location."
Are there any vacancies in this research trial?
"Affirmative. Clinicaltrials.gov data confirms that this experiment, first posted on April 20th 2018, is currently recruiting participants. The endeavour necessitates the recruitment of approximately twenty individuals from one clinical site."
Does this research contain any groundbreaking discoveries?
"As of today, 8 clinical trials are underway for Vitamin A palmitate across 10 cities in two different nations. The first study involving this drug was sponsored by Alkeus Pharmaceuticals and included 140 participants; it concluded Phase 2 approval back in 2015. In the ensuing years, an additional 31 examinations have been performed on this medication."
Who else is applying?
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