CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 9 enrolled
Drug / intervention
Vitamin A Palmitatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03478878
NCT03478878Early Ph 1Completed

An Investigation of Vitamin A Palmitate Supplementation in Patients With Reticular Pseudodrusen (RPD) and Delayed Dark Adaptation

National Eye Institute (NEI)·interventional·Posted Mar 27, 2018·Updated Apr 16, 2025

In Brief

A Early Phase 1 clinical trial evaluating Vitamin A Palmitate for Reticular Pseudodrusen (RPD) and Age-Related Macular Degeneration. Completed, enrolled 9 participants across 1 site.

Detailed 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 they eye to adjust to low light. This is known as dark adaptation. This is particularly significant in people with reticular pseudodrusen (RPD). Identifying and watching the early to middle stages of AMD and changes in dark adaptation might help researchers learn to stop the disease before it becomes severe. Taking vitamin A might help improve vision in people with RPD. Objectives: To see if taking 16,000 IU of vitamin A per day improves vision in people with RPD. Also to improve understanding of RPD and associated dark adaptation. Eligibility: Adults ages 50 and older with RPD 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 and last 4-6 hours. 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 20-40 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
20192020202120222023202420252026
First PostedMar 27, 2018
Enrollment StartMay 14, 2018
Primary CompletionJun 17, 2022
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 8.3 years ago

Interventions

Vitamin A Palmitatedrug

Provide vitamin A to participants with pre/post assessments of vision.