Clinical trial NCT04482465: Omega 3 and Vitamin D Dosage in a Population With Moderate to High Risk of AMD
Official title: Omega 3 and Vitamin D Dosage in a Population With Moderate to High Risk of Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Macular Degeneration
Vitamin D Deficiency
Keywords: micronutrients
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Laboratoires Thea
First posted: 2020-07-22
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: epidemiological intervention pilot study
Primary purpose: PREVENTION

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: concentration of vitamin D
timeFrame: at the time of the procedure
Secondary outcomes:
measure: concentration of fatty acids
timeFrame: at the time of the procedure
measure: concentration of zinc oxide
timeFrame: at the time of the procedure
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Julie Jacob, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.