<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/NCT03285399</url>
  </required_header>
  <id_info>
    <org_study_id>172226</org_study_id>
    <nct_id>NCT03285399</nct_id>
  </id_info>
  <brief_title>Bhaktapur Maternal and Child Micronutrient Study</brief_title>
  <official_title>Micronutrient Status in Breastfeeding Women and Their Children in Bhaktapur Nepal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre For International Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tribhuvan University, Nepal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Harvard School of Public Health (HSPH)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oslo and Akershus University of Applied Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre For International Health</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>
      Between February 2008 and February 2009, 500 infant-mother pairs in Bhaktapur, Nepal were&#xD;
      randomly selected in this nutritional survey. The dietary intake, nutritional status of&#xD;
      several nutrients, growth, and breastfeeding habits were measured in both the women and their&#xD;
      infants.The objective of this first phase was to estimate the intake and status of several&#xD;
      nutrients in relation to breastfeeding. These mother-child pairs were revisited around the&#xD;
      child's fifth birthday when growth, diet, and neurodevelopment was measured. The objective of&#xD;
      this phase was to create a cohort study where factors in infancy could be related with health&#xD;
      outcomes and development 5 years later.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over a period of one year, a total of 500 lactating (encompassing both exclusive and partial&#xD;
      breastfeeding) women were enrolled in the study and completed the first 24-hour dietary&#xD;
      recall. The women attended a hospital for physical examination, dietary interview, and blood&#xD;
      sampling. Blood samples were also collected from their infants who also went through a&#xD;
      detailed clinical examination&#xD;
&#xD;
      The blood samples from mothers and infant pairs were collected approximately one week apart.&#xD;
      The blood was spun down, plasma separated and transferred into storage vials immediately.&#xD;
      Plasma and blood pellets were stored in cryovials at -70 until analysis.&#xD;
&#xD;
      All women were also requested to provide one breast milk and one urine sample.&#xD;
&#xD;
      Plasma, blood pellet, urine, and breast milk was stored at -70 degrees celcius until&#xD;
      analysis.&#xD;
&#xD;
      Plasma was analyzed for iron, transferrin receptor, ferritin, cobalamin, folate, vitamin A,&#xD;
      vitamin D, vitamin E, several amino acids and other micronutrient related metabolites.&#xD;
&#xD;
      The breast milk will be analyzed for iodine, fatty acids, and several B vitamins&#xD;
&#xD;
      The urine was analyzed for iodine.&#xD;
&#xD;
      In phase 2, after 5 years we revisited the mother-child pairs and measured growth, diet, food&#xD;
      security, and neurodevelopment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 12, 2008</start_date>
  <completion_date type="Actual">February 28, 2014</completion_date>
  <primary_completion_date type="Actual">February 28, 2010</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of micronutrient deficiency</measure>
    <time_frame>1 year</time_frame>
    <description>The status and prevalence of deficiencies of several micronutrients has been estimated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Predictors for micronutrient status</measure>
    <time_frame>1 year</time_frame>
    <description>We will estimate predictors for several of the measured micronutrients using other biomarkers and clinical and demographic variables.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of anaemia in mothers and children</measure>
    <time_frame>1 year</time_frame>
    <description>Hemoglobin concentration is measured for all participants and the proportion anaemic and predictors for anaemia will be presented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neurodevelopment at 5 years</measure>
    <time_frame>5 years</time_frame>
    <description>Neurodevelopment is measured when the children are 5 using the Ages and Stages questionnaire and the NEPSY II tests. These measures will be related to micronutrient status, inflammation and stress markers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Growth during infancy and at 5 years of age</measure>
    <time_frame>5 years</time_frame>
    <description>Growth (length and weight) is measured when the children are 5 years and will be related to nutritional status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers of stress and inflammation.</measure>
    <time_frame>1 year</time_frame>
    <description>Maternal and infants markers of inflammation (CRP, neopterine, kynurenic acid, kynurenine, tryphtophane, etc) and stress (leucocyte telomere length) will be measured and related to micronutrient status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breastmilk b-vitamin concentration</measure>
    <time_frame>1 year</time_frame>
    <description>The concentration of several b-vitamins will be estimated in the breast milk and related to dietary intake and maternal and child status</description>
  </secondary_outcome>
  <enrollment type="Actual">1000</enrollment>
  <condition>Malnutrition, Infant</condition>
  <condition>Malnutrition; Anemia</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Breastmilk Plasma Red blood cells Urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        A cross-sectional survey was carried out and 500 healthy lactating women (17-44 years old)&#xD;
        were randomly selected from Bhaktapur municipality, Nepal. Bhaktapur is an urban area&#xD;
        located 15 km east of the capital Kathmandu and was chosen because of the diversity of this&#xD;
        population spanning all socio-economic strata, providing a unique opportunity to explore&#xD;
        dietary variation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  availability of consent&#xD;
&#xD;
          -  no ongoing illness&#xD;
&#xD;
          -  resides in the selected cluster&#xD;
&#xD;
          -  that household information could be obtained&#xD;
&#xD;
          -  that the mother was lactating&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refused blood sampling&#xD;
&#xD;
          -  chronic illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Months</minimum_age>
    <maximum_age>11 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tor A Strand, MD/PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bergen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Siddhi Memorial Hospital (SMH),Bhelukhel, Bhimsensthan</name>
      <address>
        <city>Bhaktapur</city>
        <zip>P.O.Box 40</zip>
        <country>Nepal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nepal</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 15, 2017</last_update_submitted>
  <last_update_submitted_qc>September 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nepal</keyword>
  <keyword>Breastfeeding</keyword>
  <keyword>Micronutrients</keyword>
  <keyword>Women</keyword>
  <keyword>Infants</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Infant Nutrition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data can be requested by contacting the principal investigator (Tor Strand) or one of the other investigators.</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/NCT03285399
org study id: 172226
nct id: NCT03285399
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Between February 2008 and February 2009, 500 infant-mother pairs in Bhaktapur, Nepal were
      randomly selected in this nutritional survey. The dietary intake, nutritional status of
      several nutrients, growth, and breastfeeding habits were measured in both the women and their
      infants.The objective of this first phase was to estimate the intake and status of several
      nutrients in relation to breastfeeding. These mother-child pairs were revisited around the
      child's fifth birthday when growth, diet, and neurodevelopment was measured. The objective of
      this phase was to create a cohort study where factors in infancy could be related with health
      outcomes and development 5 years later.
Over a period of one year, a total of 500 lactating (encompassing both exclusive and partial
      breastfeeding) women were enrolled in the study and completed the first 24-hour dietary
      recall. The women attended a hospital for physical examination, dietary interview, and blood
      sampling. Blood samples were also collected from their infants who also went through a
      detailed clinical examination

      The blood samples from mothers and infant pairs were collected approximately one week apart.
      The blood was spun down, plasma separated and transferred into storage vials immediately.
      Plasma and blood pellets were stored in cryovials at -70 until analysis.

      All women were also requested to provide one breast milk and one urine sample.

      Plasma, blood pellet, urine, and breast milk was stored at -70 degrees celcius until
      analysis.

      Plasma was analyzed for iron, transferrin receptor, ferritin, cobalamin, folate, vitamin A,
      vitamin D, vitamin E, several amino acids and other micronutrient related metabolites.

      The breast milk will be analyzed for iodine, fatty acids, and several B vitamins

      The urine was analyzed for iodine.

      In phase 2, after 5 years we revisited the mother-child pairs and measured growth, diet, food
      security, and neurodevelopment.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of micronutrient deficiency
time frame: 1 year
description: The status and prevalence of deficiencies of several micronutrients has been estimated
measure: Predictors for micronutrient status
time frame: 1 year
description: We will estimate predictors for several of the measured micronutrients using other biomarkers and clinical and demographic variables.
measure: Prevalence of anaemia in mothers and children
time frame: 1 year
description: Hemoglobin concentration is measured for all participants and the proportion anaemic and predictors for anaemia will be presented.
measure: Neurodevelopment at 5 years
time frame: 5 years
description: Neurodevelopment is measured when the children are 5 using the Ages and Stages questionnaire and the NEPSY II tests. These measures will be related to micronutrient status, inflammation and stress markers.
measure: Growth during infancy and at 5 years of age
time frame: 5 years
description: Growth (length and weight) is measured when the children are 5 years and will be related to nutritional status.
measure: Markers of stress and inflammation.
time frame: 1 year
description: Maternal and infants markers of inflammation (CRP, neopterine, kynurenic acid, kynurenine, tryphtophane, etc) and stress (leucocyte telomere length) will be measured and related to micronutrient status.
measure: Breastmilk b-vitamin concentration
time frame: 1 year
description: The concentration of several b-vitamins will be estimated in the breast milk and related to dietary intake and maternal and child status
Breastmilk Plasma Red blood cells Urine
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 2 Months
maximum age: 11 Months
healthy volunteers: No
last name: Tor A Strand, MD/PhD
role: Principal Investigator
affiliation: University of Bergen
facility: 
country: Nepal
responsible party type: Sponsor
mesh term: Malnutrition
mesh term: Infant Nutrition Disorders
sharing ipd: Undecided
ipd description: Data can be requested by contacting the principal investigator (Tor Strand) or one of the other investigators.