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

NCT04482465 | Completed

• 1 other identifier: UZLeuven S59711
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-related Macular Degeneration; Vitamin D Deficiency

Keywords

micronutrients

Outcome Measures

Primary Outcomes (1)

• concentration of vitamin D

  vitamin D deficiency

  at the time of the procedure

Secondary Outcomes (2)

• concentration of fatty acids

  at the time of the procedure

• concentration of zinc oxide

  at the time of the procedure

Study Arms (1)

pilot study 1 arm

OTHER

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

Interventions

blood sample DIAGNOSTIC_TEST

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

pilot study 1 arm

Eligibility Criteria

• Age: 55 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Laboratoires Thea: collaborator

Study Sites (1)

UZLeuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 33620690 DERIVED

MeSH Terms

Conditions

Macular Degeneration; Vitamin D Deficiency

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Julie Jacob, MD PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: blood results were communicated to each participant
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: epidemiological intervention pilot study

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 22, 2020
• Study Start: April 20, 2017
• Primary Completion: October 5, 2017
• Study Completion: October 5, 2017
• Last Updated: June 27, 2024

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)