Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03478865 · ClinicalTrials.gov registry record · Early Phase 1
Vitamin A Palmitate Supplementation in People With Age-Related Macular Degeneration (and Without Reticular Pseudodrusen) and Delayed Dark Adaptation
A Early Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 8
- Enrollment target
NCT03478865 is a Early Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 8 participants.
The verdict
NCT03478865, a Early Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
Background: Age-related macular degeneration (AMD) is an eye disease. It is the leading cause of vision loss in people over 55 in the U.S. Changes in the eye can make it difficult for the eye to adjust to low light. This is known as dark adaptation. Identifying and watching the early to middle stages of AMD and changes in dark adaptation might help researchers develop new treatments to stop the disease before it becomes severe. Taking vitamin A might help improve vision in people with AMD. Objectives: To see if taking 16,000 IU of vitamin A per day improves vision in people with AMD. Also to improve understanding of AMD and associated dark adaptation. Eligibility: Adults ages 50 and older with AMD and normal liver function Design: Participants will be screened with: Medical and eye disease history Eye exam: The pupil will be dilated with eye drops. Pictures will be taken of the retina and the inside of the eye. Including the screening visit, participants will have at least 5 visits. They will be about once a month over 6 months. Visits include: Questions about eye problems in certain light Eye exam Blood and urine tests Dark adaptation protocol: Participants will sit at a machine in a dark room. They will look into the machine and push a button when they see a light. This lasts 20-30 minutes. Participants will take a vitamin A supplement by mouth once a day for 2 months. They will record when they take the pills in a diary.
Interventions
- DRUG Vitamin A palmitate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-04-20 |
| Est. Completion | 2023-06-16 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03478865
The ClinicalTrials.gov registry entry for NCT03478865 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vitamin A palmitate is the first listed.
NCT03478865 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03478865 about?
NCT03478865 is a clinical study titled "Vitamin A Palmitate Supplementation in People With Age-Related Macular Degeneration (and Without Reticular Pseudodrusen) and Delayed Dark Adaptation". Background: Age-related macular degeneration (AMD) is an eye disease. It is the leading cause of vision loss in people over 55 in the U.S. Changes in the eye can make it difficult for the eye to adjust to low light. This is known as dark adaptation. Identifying and watching the early to middle stag...
What is the current status of trial NCT03478865?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 8 participants. The study started on 2018-04-20. Estimated completion is 2023-06-16.
What interventions are being tested in trial NCT03478865?
The interventions under investigation include: Vitamin A palmitate (DRUG).
Who is sponsoring clinical trial NCT03478865?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.