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

Vitamin D Deficiency Clinical Trial

— OVID-AMD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04482465
• Other study ID #: UZLeuven S59711
• Status: Completed
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: October 5, 2017

Study information

• Verified date: July 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 5, 2017
• Est. primary completion date: October 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration
• Vitamin D Deficiency

Intervention

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

Locations

Country	Name	City	State
Belgium	UZLeuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Laboratoires Thea

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concentration of vitamin D	vitamin D deficiency	at the time of the procedure
Secondary	concentration of fatty acids	omega 6/omega 3 ratio, DHA, EPA	at the time of the procedure
Secondary	concentration of zinc oxide	in µg/L	at the time of the procedure