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

Omega 3 and Vitamin D Dosage in a Population With Moderate to High Risk of Age-related Macular Degeneration

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.

Study Overview

• Status: Completed
• Conditions: Age-related Macular Degeneration; Vitamin D Deficiency
• Intervention / Treatment: Diagnostic test: blood sample

Detailed Description

Study population This pilot study is a multicentre epidemiological intervention study of exploratory nature, hence no power calculation was performed, aiming to demonstrate trends. The study includes 50 subjects without a control group.

The inclusion criteria of the 50 subjects are: people over 55 years old, with a STARS® score ≥10 (moderate-to-high risk for AMD). Individuals with a STARS® score <10, or taking nutritional supplements containing vitamin D or trace nutrients in the 4 months prior to enrolment, and people with grade-3 or grade-4 AMD scores according to the AREDS simplified scale, were excluded from the study.

Study Design and Procedures The study was conducted in accordance to the GCP and Declaration of Helsinki principles, and the study protocol and all relevant study documents were submitted for review to the UZ Leuven Ethics Committee. Informed consent form was obtained from the subjects prior to their enrolment in the study. All information collected was kept confidential and anonymized and used exclusively for the purposes of this study in compliance with the applicable personal data protection and processing laws.

The study was completed within a single visit. 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 using a Vacutainer system with 1 purple EDTA tube and 2 red tubes to assay for omega-3 fatty acids, EPA and DHA as well as omega-6 for the calculation of the omega-6:omega-3 (Ω6:Ω3) ratio, vitamin 25(OH)D, zinc oxide and cupric oxide. Samples were analysed by the RP Lab, Rue Emile Francqui 7, 1435 Mont-Saint-Guibert, Belgium (www.rplab.be).

Data Analysis The data were tested for normality using the Chi-Squared Goodness-of-Fit test. Data distribution was not normal for some of the assayed micronutrients, thus all data were analysed to identify trends using subject proportions (%) and descriptive statistics for not normally distributed data: median ± MAD (median absolute deviation).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZLeuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age over 55
• STARS score > or = 10 (moderate to high risk for AMD)

Exclusion Criteria:

• STARS score < 10
• persons taking nutritional supplements containing vitamin D or trace nutrients in the 4 months prior to enrollment
• persons with grade-3 or grade-4 AMD scores according to the AREDS simplified scale

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: pilot study 1 arm; 50 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 score > or = 10, not taking vitamin D or trace nutriënt containing supplements	Diagnostic test: blood sample; blood sample to determine omega6/omega 3 ratio, EPA, DHA, zinc, cupric oxide, vitamine D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
concentration of vitamin D	vitamin D deficiency	at the time of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
concentration of fatty acids	omega 6/omega 3 ratio, DHA, EPA	at the time of the procedure
concentration of zinc oxide	in µg/L	at the time of the procedure

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Laboratoires Thea
• Investigators: Principal Investigator: Julie Jacob, MD PhD, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

General Publications

• Jacob J, Mangelschots E, Michez M, Sanak SN, Leys A. Cross-Sectional Study on Vitamin D, Zinc Oxide and Fatty Acid Status in a Population with a Moderate to High Risk of AMD Identified by the STARS(R) Questionnaire. Ophthalmol Ther. 2021 Jun;10(2):299-311. doi: 10.1007/s40123-021-00335-4. Epub 2021 Feb 23.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Actual): October 5, 2017
• Study Completion (Actual): October 5, 2017

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: micronutrients
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Macular Degeneration; Vitamin D Deficiency
• Other Study ID Numbers: UZLeuven S59711

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: results will be published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No