Evaluating carotenoid levels in patients with low cholesterol conditions
Characterization of the Density of Macular Pigment in Patients With Primary Intestinal Hypocholesterolemia and Its Relation to Their Carotenoid and Anti-oxidant Status.
This study is trying to see how carotenoid levels and oxidative stress markers affect people with low cholesterol conditions like abetalipoproteinemia and chylomicron retention disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 50 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 3 sites (Bron and 2 other locations) |
| Trial ID | NCT05208879 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with genetically proven hypocholesterolemia, specifically those with abetalipoproteinemia and chylomicron retention disease. It aims to characterize carotenoid status and plasma levels of oxidative stress markers in these patients. The study will also evaluate and compare macular pigment density, which may provide insights into the nutritional status and potential visual implications for these individuals. Participants will be monitored in specialized departments at the Women's Hospital Mother Child of Lyon and the Louis Pradel Hospital.
Who should consider this trial
Good fit: Ideal candidates include genetically confirmed patients with hypocholesterolemia aged over 6 years who are being monitored in specific hospital departments.
Not a fit: Patients with allergies to local anesthetics or mydriatics, or those currently participating in other research studies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of carotenoid status in patients with low cholesterol conditions, potentially leading to improved nutritional management.
How similar studies have performed: While there is limited information on similar studies, the focus on carotenoid status in specific genetic conditions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Genetically proven family hypocholesterolemia patients, * Patients systematically monitored in the Gastroenterology and Paediatric Nutrition department of the Women's Hospital Mother Child of Lyon or in the adult endocrinology department of the GHE (Louis Pradel Hospital), * Girl/woman or boy/man over 6 years and over 12 kg at the time of inclusion (age required for cooperation on macular pigment measurement), * No objection from the patient or their parents/legal tutors in the case of a minor patient, * Patient covered by social security. Exclusion Criteria: * Allergy to local anesthetics (especially xylocaine) * Mydriatic allergy * Person participating in another research with an exclusion period still in progress at pre-inclusion * Person subject to a safeguard measure.
Where this trial is running
Bron and 2 other locations
- UF nutrition pédiatrique, Service hépatologie, gastroentérologie et nutrition pédiatrique Hôpital Femme Mère Enfant de Lyon (GHE-HFME) — Bron, France (Recruiting)
- Fédération d'endocrinologie, maladies métaboliques, diabète et nutrition Hôpital cardiovasculaire et pneumologique Louis Pradel — Bron, France (Not_yet_recruiting)
- UF nutrition pédiatrique, Service hépatologie, gastroentérologie et nutrition pédiatrique Hôpital Femme Mère Enfant de Lyon (GHE-HFME) — Bron, France (Recruiting)
Study contacts
- Principal investigator: Peretti Noël, Pr — Hospices Civils de Lyon
- Study coordinator: Peretti Noël, Pr
- Email: noel.peretti@chu-lyon.fr
- Phone: +33 472357050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.