NCT05794074

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Apr 2023

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Apr 2023Mar 2027

First Submitted

Initial submission to the registry

February 3, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 31, 2023

Status Verified

January 1, 2023

Enrollment Period

3.9 years

First QC Date

February 3, 2023

Last Update Submit

March 20, 2023

Conditions

Nutrition Deficiency (Xanth Deficiency) Due to A Particular Kind of Food

Outcome Measures

Primary Outcomes (1)

  • evolution of MPOD Baseline Vs M6

    Changes in MPOD by fundus photography (blue light autofluorescence) from baseline to 6 months of supplementation (M6) with lutein or zeaxanthin, or a combination of both, vs placebo.

    Baseline, month 6

Secondary Outcomes (3)

  • Linkage between MPDO and visual settings

    Baseline, Month 6

  • Linkage between MPOD and blood and xanth blodd count

    Baseline, Month 4 and Month 13(option)

  • Measurement of visual accuity and settings

    Baseline, Month 4, Month 7, Month 13(option)

Study Arms (4)

lutéine

EXPERIMENTAL

10 mg/d lutéine

Dietary Supplement: luteine

zeaxanthine

EXPERIMENTAL

10 mg/d zéaxanthine

Dietary Supplement: zeaxanthine

lutéine and zeaxanthine

EXPERIMENTAL

10 mg/d lutéine + 2 mg/d zéaxanthine

Dietary Supplement: luteine and zeaxanthine

placebo

PLACEBO COMPARATOR

same excipient used in the other arms with a carmine red dye

Dietary Supplement: Placebo

Interventions

luteine and zeaxanthineDIETARY_SUPPLEMENT

luteine and zeaxanthine

lutéine and zeaxanthine
luteineDIETARY_SUPPLEMENT

luteine

lutéine
zeaxanthineDIETARY_SUPPLEMENT

zeaxanthine

zeaxanthine
PlaceboDIETARY_SUPPLEMENT

Placebo

placebo

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Xanthophylls

Intervention Hierarchy (Ancestors)

CarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2023

First Posted

March 31, 2023

Study Start

April 1, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 31, 2023

Record last verified: 2023-01