<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04482465</url>
  </required_header>
  <id_info>
    <org_study_id>UZLeuven S59711</org_study_id>
    <nct_id>NCT04482465</nct_id>
  </id_info>
  <brief_title>Omega 3 and Vitamin D Dosage in a Population With Moderate to High Risk of AMD</brief_title>
  <acronym>OVID-AMD</acronym>
  <official_title>Omega 3 and Vitamin D Dosage in a Population With Moderate to High Risk of Age-related Macular Degeneration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laboratoires Thea</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives: The investigators conducted a prospective study in Belgium with the objective to&#xD;
      determine the proportion of subjects identified at moderate-to-high risk for AMD, based on&#xD;
      the STARS® questionnaire, in need of nutritional supplementation by assessing their vitamin&#xD;
      D, zinc oxide and fatty acid profile status.&#xD;
&#xD;
      Methods: This multicentre epidemiological intervention pilot study involved 50 Belgian&#xD;
      subjects with no AMD or early AMD, aged over 55, at moderate-to-high risk for AMD based on a&#xD;
      simplified AMD risk assessment scale (STARS®) score ≥ 10, not taking vitamin D or trace&#xD;
      nutrient containing supplements. Outcome data was collected during a one-time subject&#xD;
      interview comprising of clinical eye examinations (typically visual acuity), the STARS®&#xD;
      questionnaire, visual acuity assessment, an OCT scan on the macula, and fundus photography.&#xD;
      Blood samples were collected from the patients and serum analysis was performed to determine&#xD;
      the levels of omega-6 to omega-3 ratio, EPA and DHA, zinc and cupric oxide, and vitamin D,&#xD;
      recognised as key nutrients involved in AMD pathophysiology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study population This pilot study is a multicentre epidemiological intervention study of&#xD;
      exploratory nature, hence no power calculation was performed, aiming to demonstrate trends.&#xD;
      The study includes 50 subjects without a control group.&#xD;
&#xD;
      The inclusion criteria of the 50 subjects are: people over 55 years old, with a STARS® score&#xD;
      ≥10 (moderate-to-high risk for AMD). Individuals with a STARS® score &lt;10, or taking&#xD;
      nutritional supplements containing vitamin D or trace nutrients in the 4 months prior to&#xD;
      enrolment, and people with grade-3 or grade-4 AMD scores according to the AREDS simplified&#xD;
      scale, were excluded from the study.&#xD;
&#xD;
      Study Design and Procedures The study was conducted in accordance to the GCP and Declaration&#xD;
      of Helsinki principles, and the study protocol and all relevant study documents were&#xD;
      submitted for review to the UZ Leuven Ethics Committee. Informed consent form was obtained&#xD;
      from the subjects prior to their enrolment in the study. All information collected was kept&#xD;
      confidential and anonymized and used exclusively for the purposes of this study in compliance&#xD;
      with the applicable personal data protection and processing laws.&#xD;
&#xD;
      The study was completed within a single visit. Outcome data was collected during a one-time&#xD;
      subject interview comprising of clinical eye examinations (typically visual acuity), the&#xD;
      STARS® questionnaire, visual acuity assessment, an OCT scan on the macula, and fundus&#xD;
      photography. Blood samples were collected using a Vacutainer system with 1 purple EDTA tube&#xD;
      and 2 red tubes to assay for omega-3 fatty acids, EPA and DHA as well as omega-6 for the&#xD;
      calculation of the omega-6:omega-3 (Ω6:Ω3) ratio, vitamin 25(OH)D, zinc oxide and cupric&#xD;
      oxide. Samples were analysed by the RP Lab, Rue Emile Francqui 7, 1435 Mont-Saint-Guibert,&#xD;
      Belgium (www.rplab.be).&#xD;
&#xD;
      Data Analysis The data were tested for normality using the Chi-Squared Goodness-of-Fit test.&#xD;
      Data distribution was not normal for some of the assayed micronutrients, thus all data were&#xD;
      analysed to identify trends using subject proportions (%) and descriptive statistics for not&#xD;
      normally distributed data: median ± MAD (median absolute deviation).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 20, 2017</start_date>
  <completion_date type="Actual">October 5, 2017</completion_date>
  <primary_completion_date type="Actual">October 5, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>epidemiological intervention pilot study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>blood results were communicated to each participant</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>concentration of vitamin D</measure>
    <time_frame>at the time of the procedure</time_frame>
    <description>vitamin D deficiency</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>concentration of fatty acids</measure>
    <time_frame>at the time of the procedure</time_frame>
    <description>omega 6/omega 3 ratio, DHA, EPA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>concentration of zinc oxide</measure>
    <time_frame>at the time of the procedure</time_frame>
    <description>in µg/L</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Age-related Macular Degeneration</condition>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>pilot study 1 arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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 &gt; or = 10, not taking vitamin D or trace nutriënt containing supplements</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>blood sample</intervention_name>
    <description>blood sample to determine omega6/omega 3 ratio, EPA, DHA, zinc, cupric oxide, vitamine D</description>
    <arm_group_label>pilot study 1 arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age over 55&#xD;
&#xD;
          -  STARS score &gt; or = 10 (moderate to high risk for AMD)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  STARS score &lt; 10&#xD;
&#xD;
          -  persons taking nutritional supplements containing vitamin D or trace nutrients in the&#xD;
             4 months prior to enrollment&#xD;
&#xD;
          -  persons with grade-3 or grade-4 AMD scores according to the AREDS simplified scale&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julie Jacob, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitaire Ziekenhuizen KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZLeuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>micronutrients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Vitamin D Deficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>results will be published</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT04482465/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04482465
org study id: UZLeuven S59711
nct id: NCT04482465
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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 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).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: epidemiological intervention pilot study
primary purpose: Prevention
masking: None (Open Label)
masking description: blood results were communicated to each participant
measure: concentration of vitamin D
time frame: at the time of the procedure
description: vitamin D deficiency
measure: concentration of fatty acids
time frame: at the time of the procedure
description: omega 6/omega 3 ratio, DHA, EPA
measure: concentration of zinc oxide
time frame: at the time of the procedure
description: in µg/L
arm group label: pilot study 1 arm
arm group type: Other
description: 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
intervention type: Diagnostic Test
intervention name: blood sample
description: blood sample to determine omega6/omega 3 ratio, EPA, DHA, zinc, cupric oxide, vitamine D
arm group label: pilot study 1 arm
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Julie Jacob, MD PhD
role: Principal Investigator
affiliation: Universitaire Ziekenhuizen KU Leuven
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Vitamin D Deficiency
sharing ipd: No
ipd description: results will be published
provided document: 