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Vitamin

Vitamin A palmitate for Choroideremia (DARC Trial)

N/A

Waitlist Available

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measurements at 0, 4, and 8 months

Awards & highlights

DARC Trial 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.

DARC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in dark adaptometry

Change in dark-adapted full-field visual field sensitivity

Change in dark-adapted macular visual field sensitivity

Secondary outcome measures

Change in best corrected visual acuity

Change in full-field light-adapted visual field sensitivity

Change in light-adapted macular visual field sensitivity

+7 more

DARC Trial Design

1Treatment groups

Experimental Treatment

Group I: Vitamin A palmitateExperimental Treatment1 Intervention

Vitamin A palmitate, 15,000 IU daily for 4 months

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Who is running the clinical trial?

Duke UniversityLead Sponsor

2,363 Previous Clinical Trials

3,420,506 Total Patients Enrolled

Foundation Fighting BlindnessOTHER

14 Previous Clinical Trials

22,352 Total Patients Enrolled

2 Trials studying Choroideremia

20,006 Patients Enrolled for Choroideremia

Frequently Asked Questions

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

Are any new participants currently being accepted into this experiment?

"This clinical trial is no longer accepting participants, as highlighted on the data hosted by clinicaltrials.gov. The study was first posted on October 1st 2022 and edited for the last time on September 9th 2022. Luckily, there are 3 other trials currently searching for candidates to join their respective teams of researchers."

Answered by AI

What objectives are the researchers hoping to accomplish through this investigation?

"This clinical trial is designed to monitor the impact of Vitamin A supplementation on dark adaptometry over a period of eight months. The baseline measurement will be taken at zero, with subsequent measurements being made after 4 and 8 month periods. Other associated secondary outcomes include changes in best corrected visual acuity (as measured by ETDRS chart), retinal pigmented epithelium atrophy (assessed via Optos wide-field fundus auto-fluorescence), and full-field light adapted visual field sensitivity (via Octopus 172 point GATE semi automated kinetic perimetry)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Dark-Adapted Retinal Function Response in Choroideremia (DARC) Study

2023. "The Dark-Adapted Retinal Function Response in Choroideremia (DARC) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05045703.