Role of Xanthophylls in Visual Function (NCT05794074) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Role of Xanthophylls in Visual Function
48 participantsStarted 2023-04-01
Plain-language summary
Ecy of lutein supplementation alone, or zeaxanthin supplementation alone, or a combination of both, compared to placebo, on the evolution of macular pigment density (MPOD) measured by fundus photography in XANTH-deficient patients receiving enteral nutrition.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* On exclusive enteral nutrition for at least 6 months
* Exclusive enteral nutrition that is intended to be continued for at least 6 more months.
* No XANTH supplementation in the last 6 months.
* Able to sit up to allow visual examinations to be performed
* Sufficient understanding to perform visual examinations, at the discretion of the physician
* Written consent signed by the patient or agreement of their carer, trusted person, relative, family for patients with cognitive impairment (assessed using an MMS test). A patient with an MMSE test result ≤ 24 will be considered as having cognitive disorders.
Exclusion Criteria:
* Current treatment with hydroxychloroquine or any other drug known to cause ocular toxicity
* Visually impaired patient: patient unable to read text (font size 11) at close range, with visual correction if the patient usually wears it
* Unoperated cataracts in both eyes
* Pregnant or breastfeeding woman
* Patient under legal protection: guardianship or curatorship
* Participation in other research in the same field of dietary supplementation, which may interfere with the results of this research.
Secondary exclusion criteria :
* Absence of XANTH (lutein and zeaxanthin) deficiency\* in the blood sample taken at inclusion.
* Physical, ophthalmological or cognitive characteristics, evaluated at the Quinze-Vingt ophthalmological examination, which do not allow a reliable measurement of MPOD or of all the settings of visual function.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.