<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/NCT03826654</url>
  </required_header>
  <id_info>
    <org_study_id>24</org_study_id>
    <nct_id>NCT03826654</nct_id>
  </id_info>
  <brief_title>Assessment of the Efficacy of Vitamin D-fortified Oil in Healthy Adults</brief_title>
  <official_title>Formulation of Vitamin D-fortified Sunflower Oil and Evaluation of the Efficacy of Its Consumption in Healthy Adults: a Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Nutrition and Food Technology Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Nutrition and Food Technology Institute</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of this study is to evaluate the efficacy of daily intake of fortified sunflower oil&#xD;
      with vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy&#xD;
      subjects compared to plain oil.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sixty apparently healthy subjects will be selected. Participants who are receiving vitamin D,&#xD;
      calcium or omega-3 supplements within the last three months will be excluded. Subjects will&#xD;
      be assigned randomly to one of the two intervention groups: 1.fortified sunflower oil, 2.&#xD;
      plain bread+vitamin D supplements,3. plain bread+placebo. Each participant will consume 50 g&#xD;
      of oil every day for 2 months.&#xD;
&#xD;
      At the first and last visits, dietary and laboratory assessments will be performed for all&#xD;
      subjects. Primary outcomes are the improvement in vitamin D status and secondary outcome is&#xD;
      the improvement of glycemic and lipidemic markers and prevention of problems related to&#xD;
      hypovitaminosis D.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">July 1, 2018</completion_date>
  <primary_completion_date type="Actual">April 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>25-hydroxyvitamin D (nmol/L)</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>serum glucose (mg/dL)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum triglyceride (mg/dL)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum total cholesterol (mg/dL)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum LDL</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum HDL</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum PTH (pg/mL)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>fortified oil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>daily intake of fortified sunflower oil (700IU vitamin D/ 35g)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>daily intake of plain oil</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>fortified oil</intervention_name>
    <description>35 g fortified sunflower oil</description>
    <arm_group_label>fortified oil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>plain oil</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20 to 60 years&#xD;
&#xD;
          -  healthy subjects&#xD;
&#xD;
          -  no receiving vitamin D or omega-3 supplement in past 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - receiving vitamin D or omega-3 supplement during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tirang R. Neyestani, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute (NNFTRI) and Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute (NNFTRI) and Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Nutrition and Food Technology Institute</investigator_affiliation>
    <investigator_full_name>Tirang R. Neyestani, Ph.D.</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>vitamin D</keyword>
  <keyword>fortified oil</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03826654
org study id: 24
nct id: NCT03826654
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the efficacy of daily intake of fortified sunflower oil
      with vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy
      subjects compared to plain oil.
Sixty apparently healthy subjects will be selected. Participants who are receiving vitamin D,
      calcium or omega-3 supplements within the last three months will be excluded. Subjects will
      be assigned randomly to one of the two intervention groups: 1.fortified sunflower oil, 2.
      plain bread+vitamin D supplements,3. plain bread+placebo. Each participant will consume 50 g
      of oil every day for 2 months.

      At the first and last visits, dietary and laboratory assessments will be performed for all
      subjects. Primary outcomes are the improvement in vitamin D status and secondary outcome is
      the improvement of glycemic and lipidemic markers and prevention of problems related to
      hypovitaminosis D.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: 25-hydroxyvitamin D (nmol/L)
time frame: 8 weeks
measure: serum glucose (mg/dL)
time frame: 8 weeks
measure: serum triglyceride (mg/dL)
time frame: 8 weeks
measure: serum total cholesterol (mg/dL)
time frame: 8 weeks
measure: serum LDL
time frame: 8 weeks
measure: serum HDL
time frame: 8 weeks
measure: serum PTH (pg/mL)
time frame: 8 weeks
arm group label: fortified oil
arm group type: Experimental
description: daily intake of fortified sunflower oil (700IU vitamin D/ 35g)
arm group label: control
arm group type: Placebo Comparator
description: daily intake of plain oil
intervention type: Dietary Supplement
intervention name: fortified oil
description: 35 g fortified sunflower oil
arm group label: fortified oil
intervention type: Dietary Supplement
intervention name: Placebo
description: plain oil
arm group label: control
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tirang R. Neyestani, PhD
role: Study Chair
affiliation: Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute (NNFTRI) and Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: National Nutrition and Food Technology Institute
investigator full name: Tirang R. Neyestani, Ph.D.
investigator title: Prof.
sharing ipd: Undecided