Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04482465
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2020-07-07
Brief Title:
Omega 3 and Vitamin D Dosage in a Population With Moderate to High Risk of AMD
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Omega 3 and Vitamin D Dosage in a Population With Moderate to High Risk of Age-related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OVID-AMD
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
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-6omega-3 Ω6Ω3 ratio vitamin 25OHD zinc oxide and cupric oxide Samples were analysed by the RP Lab Rue Emile Francqui 7 1435 Mont-Saint-Guibert Belgium wwwrplabbe
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
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-6omega-3 Ω6Ω3 ratio vitamin 25OHD zinc oxide and cupric oxide Samples were analysed by the RP Lab Rue Emile Francqui 7 1435 Mont-Saint-Guibert Belgium wwwrplabbe
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None