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Omega 3 and Vitamin D Dosage in a Population With Moderate to High Risk of AMD

NCT04482465 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-06-27

No results posted yet for this study

Summary

Objectives: The investigators conducted a prospective study in Belgium with the objective to determine the proportion of subjects identified at moderate-to-high risk for AMD, based on the STARS® questionnaire, in need of nutritional supplementation by assessing their vitamin D, zinc oxide and fatty acid profile status.

Methods: This multicentre epidemiological intervention pilot study involved 50 Belgian subjects with no AMD or early AMD, aged over 55, at moderate-to-high risk for AMD based on a simplified AMD risk assessment scale (STARS®) score ≥ 10, not taking vitamin D or trace nutrient containing supplements. Outcome data was collected during a one-time subject interview comprising of clinical eye examinations (typically visual acuity), the STARS® questionnaire, visual acuity assessment, an OCT scan on the macula, and fundus photography. Blood samples were collected from the patients and serum analysis was performed to determine the levels of omega-6 to omega-3 ratio, EPA and DHA, zinc and cupric oxide, and vitamin D, recognised as key nutrients involved in AMD pathophysiology.

Conditions

  • Age-related Macular Degeneration
  • Vitamin D Deficiency

Interventions

DIAGNOSTIC_TEST

blood sample

blood sample to determine omega6/omega 3 ratio, EPA, DHA, zinc, cupric oxide, vitamine D

Sponsors & Collaborators

  • Laboratoires Thea

    collaborator INDUSTRY

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Julie Jacob, MD PhD · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2017-10-05
Completion
2017-10-05

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04482465 on ClinicalTrials.gov