Vitamin A Palmitate Supplementation in People With Age-Related Macular Degeneration (and Without Reticular Pseudodrusen) and Delayed Dark Adaptation
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|ClinicalTrials.gov Identifier: NCT03478865|
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : March 8, 2019
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.
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.
Adults ages 50 and older with AMD and normal liver function
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
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.
|Condition or disease||Intervention/treatment||Phase|
|AMD||Drug: Vitamin A palmitate||Early Phase 1|
Objective: The objective of this study is to investigate the potential efficacy of vitamin A palmitate in improving dark adaptation in participants with age-related macular degeneration (AMD) and abnormal dark adaptation.
Study Population: Ten participants will be initially accrued, however, up to twenty participants with AMD who meet the eligibility criteria may be enrolled. In the event that a participant withdraws from the study prior to receiving two months of study supplementation for a reason unrelated to an adverse reaction, an additional participant will be accrued. A maximum of ten additional participants may be accrued in order to obtain ten participants for the primary outcome analysis.
Design: This is a pilot, uncontrolled, prospective, single center study to investigate the potential efficacy of vitamin A palmitate in improving dark adaptation in participants with AMD and abnormal dark adaptation.
Outcome Measures: The primary outcome is the measurement of dark adaptation parameters (thresholds and kinetics) by the following: dark adaptation times as measured by the AdaptDx comparing before and after vitamin A palmitate supplementation and dark adaptation parameters as measured by the Medmont comparing before and after vitamin A palmitate supplementation. The secondary outcomes are changes in low luminance visual acuity (LLVA) and changes in patient reported outcomes as measured by the low luminance questionnaire (LLQ).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Investigation of Vitamin A Palmitate Supplementation in Patients With Age-Related Macular Degeneration (and Without Reticular Pseudodrusen) and Delayed Dark Adaptation|
|Actual Study Start Date :||April 20, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||January 1, 2021|
Drug: Vitamin A palmitate
vitamin A palmitate 16,000 IU daily by mouth for two months
- Measurement of dark adaptation as measured by AdaptDX and Medmont comparing pre- and post-vitamin A palmitate supplementation. [ Time Frame: 90 days ]
- Changes in LLVA and changes in patient reported outcomes as measured by the LLQ. [ Time Frame: 90 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478865
|Contact: Angel H Garced, R.N.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Catherine A Cukras, M.D.||National Eye Institute (NEI)|