Vitamin A palmitate for Choroideremia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Choroideremia
Vitamin A palmitate - DietarySupplement
Eligibility
Any Age
Male
What conditions do you have?
Select

Study Summary

This trial is testing whether oral vitamin A supplementation can improve night time and peripheral vision in people with choroideremia, a disorder that causes progressive vision loss and eventual blindness.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 10 Secondary · Reporting Duration: Measurements at 0, 4, and 8 months. The 0 months measurement will serve as the baseline. The 4 month measurement will assess change due to vitamin A supplementation. The 8 month measurement will assess reversal of this change following washout period

Month 8
Change in liver function
Month 8
Change in best corrected visual acuity
Change in dark adaptometry
Change in dark-adapted full-field visual field sensitivity
Change in dark-adapted macular visual field sensitivity
Change in full-field light-adapted visual field sensitivity
Change in light-adapted macular visual field sensitivity
Change in low luminance visual acuity
Change in retinal pigmented epithelium (RPE) atrophy by color photography
Change in retinal pigmented epithelium (RPE) atrophy by fundoscopy
Change in retinal pigmented epithelium (RPE) atrophy by fundus autofluorescence
Change in retinal pigmented epithelium (RPE) atrophy by optical coherence tomography
Change in serum vitamin A levels

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Vitamin A palmitate
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Vitamin A palmitate · No Placebo Group · N/A

Vitamin A palmitate
DietarySupplement
Experimental Group · 1 Intervention: Vitamin A palmitate · Intervention Types: DietarySupplement

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: measurements at 0, 4, and 8 months. the 0 months measurement will serve as the baseline. the 4 month measurement will assess change due to vitamin a supplementation. the 8 month measurement will assess reversal of this change following washout period

Who is running the clinical trial?

Foundation Fighting BlindnessOTHER
14 Previous Clinical Trials
22,351 Total Patients Enrolled
2 Trials studying Choroideremia
20,006 Patients Enrolled for Choroideremia
Duke UniversityLead Sponsor
2,159 Previous Clinical Trials
3,188,568 Total Patients Enrolled

Eligibility Criteria

Age Any Age · Male Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: November 8th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.