← Back to Search

Vitamin Supplement

Vitamin A Supplementation for Age-Related Macular Degeneration

Phase < 1
Waitlist Available
Led By Emily Y Chew, M.D.
Research Sponsored by National Eye Institute (NEI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be 50 years of age or older
Participant must agree to not take greater than or equal to 8000 IU vitamin A palmitate outside the study supplementation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and one month after completing supplementation
Awards & highlights

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.

Who is the study for?
This trial is for adults over 50 with Age-Related Macular Degeneration (AMD) and normal liver function. They must not be on high doses of vitamin A outside the study, agree to contraception if applicable, and not participate in other studies or have conditions that interfere with this trial.Check my eligibility
What is being tested?
The trial tests whether taking a daily dose of 16,000 IU of Vitamin A palmitate improves vision in AMD patients. It involves at least five visits over six months for eye exams, blood and urine tests, and dark adaptation assessments.See study design
What are the potential side effects?
Potential side effects are not detailed but may include issues related to high doses of Vitamin A such as skin changes, pain in bones or joints, headache or nausea. Liver function will be monitored due to the risk associated with Vitamin A toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 50 years old or older.
Select...
I agree not to take more than 8000 IU of vitamin A palmitate outside the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and one month, baseline and two months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and one month, baseline and two months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The measurement of dark adaptation parameters (threshold and kinetics)
Secondary outcome measures
Changes in LLVA and LLQ
Changes in dark adaptation measures by AdaptDx and Medmont

Trial Design

1Treatment groups
Experimental Treatment
Group I: ParticipantsExperimental Treatment1 Intervention
Participants with age-related macular degeneration

Find a Location

Who is running the clinical trial?

National Eye Institute (NEI)Lead Sponsor
546 Previous Clinical Trials
1,403,429 Total Patients Enrolled
Emily Y Chew, M.D.Principal InvestigatorNational Eye Institute (NEI)
15 Previous Clinical Trials
2,872 Total Patients Enrolled
Catherine A Cukras, M.D.Principal InvestigatorNational Eye Institute (NEI)
11 Previous Clinical Trials
1,557 Total Patients Enrolled

Media Library

Vitamin A Palmitate (Vitamin Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03478865 — Phase < 1
Age-Related Macular Degeneration Research Study Groups: Participants
Age-Related Macular Degeneration Clinical Trial 2023: Vitamin A Palmitate Highlights & Side Effects. Trial Name: NCT03478865 — Phase < 1
Vitamin A Palmitate (Vitamin Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03478865 — Phase < 1

Frequently Asked Questions

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

What therapeutic purpose does Vitamin A palmitate serve?

"Vitamin A palmitate is a reliable remedy for ailments associated with Vitamin d and A scarcity."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
65+
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria
~1 spots leftby Mar 2025