<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/NCT03251664</url>
  </required_header>
  <id_info>
    <org_study_id>AAHB-217/15</org_study_id>
    <nct_id>NCT03251664</nct_id>
  </id_info>
  <brief_title>Food Groups Associated With Anaemia in Pregnant Women</brief_title>
  <official_title>The Relation of Locally Available Food Items With Anemia Status Among Pregnant Women in Ethiopia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tehran University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tehran University of Medical Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the association between locally consumed food items with anemia among&#xD;
      pregnant women, in Addis Ababa city, Ethiopia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prevention of anemia among women, particularly pregnant women, is a priority nutrition agenda&#xD;
      in Ethiopia. Anemia is a significant contributor to poor pregnancy outcomes, including low&#xD;
      birth weight and maternal mortality. Anemia is of multiple influences, which in most of the&#xD;
      cases include dietary factors. Consumption food items rich in iron and other nutrients&#xD;
      involved in red blood cell production promotes optimal hemoglobin level. Dark green leafy&#xD;
      vegetables, meat, and beans are some of the food groups reported to be associated with lesser&#xD;
      risk of anemia. Studies on the relation of indigenous food items with health outcome are&#xD;
      limited in developing countries. For example, teff, consumed only in Ethiopia and parts of&#xD;
      Eritrea, is traditionally believed to be protective of anemia because of its high iron&#xD;
      content, but Khat chewing, a pervasive social practice in Ethiopia, has been associated with&#xD;
      restrictive eating pattern and anemia. In this study, the association of locally consumed&#xD;
      food groups with anemia was investigated among pregnant Ethiopian women.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2015</start_date>
  <completion_date type="Actual">February 20, 2016</completion_date>
  <primary_completion_date type="Actual">February 20, 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Food items/groups association with anemia</measure>
    <time_frame>October 2015 to February 2016</time_frame>
    <description>Relation of food groups with anemia risk</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reproductive factors associated with anemia</measure>
    <time_frame>October 2015 to February 2016</time_frame>
    <description>Relation of reproductive and obstetrics history with anemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sociodemographic and economic factors association with anemia</measure>
    <time_frame>October 2015 to February 2016</time_frame>
    <description>Relation of socioeconomic factors with anemia</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">592</enrollment>
  <condition>Anemia</condition>
  <condition>Dietary Habits</condition>
  <condition>Food Habits</condition>
  <arm_group>
    <arm_group_label>Anemic</arm_group_label>
    <description>Hemoglobin &lt;11 g/l</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-anemic</arm_group_label>
    <description>Hemoglobin 11 g/l (and above)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Food groups consumed</intervention_name>
    <arm_group_label>Anemic</arm_group_label>
    <arm_group_label>Non-anemic</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women in Addis Ababa city, Ethiopia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Age 18 years and above&#xD;
&#xD;
          -  Residence in Addis Ababa city&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious medical illness&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Ahmad Esmaillzadeh, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tehran University of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Addis Ababa Health Bureau</name>
      <address>
        <city>Addis Ababa</city>
        <country>Ethiopia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ethiopia</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 12, 2017</study_first_submitted>
  <study_first_submitted_qc>August 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tehran University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Shimels Hussien Mohammed</investigator_full_name>
    <investigator_title>Community Nutrition Researcher</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Not yet decided.</ipd_description>
  </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/NCT03251664
org study id: AAHB-217/15
nct id: NCT03251664
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study investigates the association between locally consumed food items with anemia among
      pregnant women, in Addis Ababa city, Ethiopia.
Prevention of anemia among women, particularly pregnant women, is a priority nutrition agenda
      in Ethiopia. Anemia is a significant contributor to poor pregnancy outcomes, including low
      birth weight and maternal mortality. Anemia is of multiple influences, which in most of the
      cases include dietary factors. Consumption food items rich in iron and other nutrients
      involved in red blood cell production promotes optimal hemoglobin level. Dark green leafy
      vegetables, meat, and beans are some of the food groups reported to be associated with lesser
      risk of anemia. Studies on the relation of indigenous food items with health outcome are
      limited in developing countries. For example, teff, consumed only in Ethiopia and parts of
      Eritrea, is traditionally believed to be protective of anemia because of its high iron
      content, but Khat chewing, a pervasive social practice in Ethiopia, has been associated with
      restrictive eating pattern and anemia. In this study, the association of locally consumed
      food groups with anemia was investigated among pregnant Ethiopian women.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Food items/groups association with anemia
time frame: October 2015 to February 2016
description: Relation of food groups with anemia risk
measure: Reproductive factors associated with anemia
time frame: October 2015 to February 2016
description: Relation of reproductive and obstetrics history with anemia
measure: Sociodemographic and economic factors association with anemia
time frame: October 2015 to February 2016
description: Relation of socioeconomic factors with anemia
arm group label: Anemic
description: Hemoglobin <11 g/l
arm group label: Non-anemic
description: Hemoglobin 11 g/l (and above)
intervention type: Dietary Supplement
intervention name: Food groups consumed
arm group label: Anemic
arm group label: Non-anemic
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
last name: Ahmad Esmaillzadeh, PhD
role: Principal Investigator
affiliation: Tehran University of Medical Sciences
facility: 
country: Ethiopia
responsible party type: Principal Investigator
investigator affiliation: Tehran University of Medical Sciences
investigator full name: Shimels Hussien Mohammed
investigator title: Community Nutrition Researcher
mesh term: Anemia
sharing ipd: Undecided
ipd description: Not yet decided.