<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/NCT04451395</url>
  </required_header>
  <id_info>
    <org_study_id>2020-3676-10314</org_study_id>
    <nct_id>NCT04451395</nct_id>
  </id_info>
  <brief_title>Investigating Pathways Between Maternal Nutritional Status, Breastmilk Composition, and Infant Linear Growth in Rural Pakistan</brief_title>
  <official_title>Investigating Pathways Between Maternal Nutritional Status, Breastmilk Composition, and Infant Linear Growth in Rural Pakistan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aga Khan University</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>
      Breastmilk is considered optimal for infant growth and development. However, evidence&#xD;
      suggests that breastmilk composition can vary according to maternal nutritional status. Among&#xD;
      women in Pakistan, there is a high burden of undernutrition and micronutrient deficiencies.&#xD;
      As well, the prevalence of early stunting among Pakistani infants is high. Using a&#xD;
      hypothesized pathway model, this study will assess pathways between maternal nutritional&#xD;
      status, breastmilk composition, and infant linear growth. This is a substudy to the Matiari&#xD;
      emPowerment and Preconception Supplementation (MaPPS) Trial (ClinicalTrials.gov Identifier:&#xD;
      NCT03287882).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 5, 2020</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maternal BMI</measure>
    <time_frame>3 months postpartum</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal dietary diversity score</measure>
    <time_frame>3 months postpartum</time_frame>
    <description>Minimum score: 0, maximum score: 10</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal hemoglobin concentration</measure>
    <time_frame>3 months postpartum</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal supplement adherence</measure>
    <time_frame>3 months postpartum</time_frame>
    <description>Determined by report (options: 0, 25, 50, 75, or 100%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breastmilk macronutrient composition</measure>
    <time_frame>3 months postpartum</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Breastmilk micronutrient composition</measure>
    <time_frame>3 months postpartum</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant length</measure>
    <time_frame>3 months postpartum</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infant weight</measure>
    <time_frame>3 months postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant middle-upper arm circumference</measure>
    <time_frame>3 months postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant head circumference</measure>
    <time_frame>3 months postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breastmilk bioactive composition</measure>
    <time_frame>3 months postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breastmilk microbiome</measure>
    <time_frame>3 months postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant microbiome</measure>
    <time_frame>3 months postpartum</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">196</enrollment>
  <condition>Breast Milk Collection</condition>
  <condition>Infant Development</condition>
  <arm_group>
    <arm_group_label>Multiple micronutrients (UNIMMAP composition)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention is an oral tablet containing 15 different vitamins and minerals at the UNIMMAP composition (includes 30 mg iron, 400 μg folic acid, 15 mg zinc, 2 mg copper, 65 μg selenium, 800 μg RE vitamin A, 1.4 mg vitamin B1, 1.4 mg vitamin B2, 18 mg niacin, 1.9 mg vitamin B6, 2.6 μg vitamin B12, 70 mg vitamin C, 5 μg vitamin D, 10 mg vitamin E and 150 μg iodine). Each tablet is small (approximately 10 mm diameter) and has been procured using the UNICEF supply catalogue. A single MMN supplementation dose will consist of a single tablet..The supplement is provided within the parent trial.&#xD;
Other Name: UNICEF, Micronutrient tabs, pregnancy/PAC-1000</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Daily iron and folic acid supplementation provided through the existing public health system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Multiple micronutrients (UNIMMAP composition)</intervention_name>
    <description>The intervention is an oral tablet containing 15 different vitamins and minerals at the UNIMMAP composition (includes 30 mg iron, 400 μg folic acid, 15 mg zinc, 2 mg copper, 65 μg selenium, 800 μg RE vitamin A, 1.4 mg vitamin B1, 1.4 mg vitamin B2, 18 mg niacin, 1.9 mg vitamin B6, 2.6 μg vitamin B12, 70 mg vitamin C, 5 μg vitamin D, 10 mg vitamin E and 150 μg iodine). Each tablet is small (approximately 10 mm diameter) and has been procured using the UNICEF supply catalogue. A single MMN supplementation dose will consist of a single tablet.&#xD;
Other Name: UNICEF, Micronutrient tabs, pregnancy/PAC-1000</description>
    <arm_group_label>Multiple micronutrients (UNIMMAP composition)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled in the MaPPS Trial&#xD;
&#xD;
          -  Mothers must report practicing exclusive or predominant breastfeeding (i.e.,&#xD;
             breastmilk only or breastmilk and non-nutritive feeds only)&#xD;
&#xD;
          -  The infant must be term-born (&gt;37 weeks gestation)&#xD;
&#xD;
          -  Infant must be 3 months ± 30 days old at the time of recruitment&#xD;
&#xD;
          -  Mothers must be willing to provide a complete breastmilk expression from one breast&#xD;
&#xD;
          -  Intervention arm only: mother reports compliance with study-administered MMN&#xD;
             supplements at least 50% of the time (i.e., 4 out of 7 days per week)&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mother reports mixed feeding in her infant with nutritive feeds (i.e., any provision&#xD;
             of formula or animal milk)&#xD;
&#xD;
          -  The infant was born preterm (earlier than 37 weeks gestation)&#xD;
&#xD;
          -  Mother does not wish to provide a complete breast expression of one breast&#xD;
&#xD;
          -  Intervention arm: mother reports compliance with MMN supplements &lt;50% of the time&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Matiari Research and Training Centre</name>
      <address>
        <city>Matiari</city>
        <state>Sindh</state>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>July 26, 2021</last_update_submitted>
  <last_update_submitted_qc>July 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University</investigator_affiliation>
    <investigator_full_name>Dr Zulfiqar Ahmed Bhutta</investigator_full_name>
    <investigator_title>Founding Chair, Centre of Excellence in Women and Child Health</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Micronutrients</mesh_term>
    <mesh_term>Trace Elements</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Please contact the Primary Investigator directly for more details.</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/NCT04451395
org study id: 2020-3676-10314
nct id: NCT04451395
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Breastmilk is considered optimal for infant growth and development. However, evidence
      suggests that breastmilk composition can vary according to maternal nutritional status. Among
      women in Pakistan, there is a high burden of undernutrition and micronutrient deficiencies.
      As well, the prevalence of early stunting among Pakistani infants is high. Using a
      hypothesized pathway model, this study will assess pathways between maternal nutritional
      status, breastmilk composition, and infant linear growth. This is a substudy to the Matiari
      emPowerment and Preconception Supplementation (MaPPS) Trial (ClinicalTrials.gov Identifier:
      NCT03287882).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Maternal BMI
time frame: 3 months postpartum
measure: Maternal dietary diversity score
time frame: 3 months postpartum
description: Minimum score: 0, maximum score: 10
measure: Maternal hemoglobin concentration
time frame: 3 months postpartum
measure: Maternal supplement adherence
time frame: 3 months postpartum
description: Determined by report (options: 0, 25, 50, 75, or 100%)
measure: Breastmilk macronutrient composition
time frame: 3 months postpartum
measure: Breastmilk micronutrient composition
time frame: 3 months postpartum
measure: Infant length
time frame: 3 months postpartum
measure: Infant weight
time frame: 3 months postpartum
measure: Infant middle-upper arm circumference
time frame: 3 months postpartum
measure: Infant head circumference
time frame: 3 months postpartum
measure: Breastmilk bioactive composition
time frame: 3 months postpartum
measure: Breastmilk microbiome
time frame: 3 months postpartum
measure: Infant microbiome
time frame: 3 months postpartum
arm group label: Multiple micronutrients (UNIMMAP composition)
arm group type: Experimental
description: The intervention is an oral tablet containing 15 different vitamins and minerals at the UNIMMAP composition (includes 30 mg iron, 400 μg folic acid, 15 mg zinc, 2 mg copper, 65 μg selenium, 800 μg RE vitamin A, 1.4 mg vitamin B1, 1.4 mg vitamin B2, 18 mg niacin, 1.9 mg vitamin B6, 2.6 μg vitamin B12, 70 mg vitamin C, 5 μg vitamin D, 10 mg vitamin E and 150 μg iodine). Each tablet is small (approximately 10 mm diameter) and has been procured using the UNICEF supply catalogue. A single MMN supplementation dose will consist of a single tablet..The supplement is provided within the parent trial.
Other Name: UNICEF, Micronutrient tabs, pregnancy/PAC-1000
arm group label: Standard of care
arm group type: No Intervention
description: Daily iron and folic acid supplementation provided through the existing public health system.
intervention type: Dietary Supplement
intervention name: Multiple micronutrients (UNIMMAP composition)
description: The intervention is an oral tablet containing 15 different vitamins and minerals at the UNIMMAP composition (includes 30 mg iron, 400 μg folic acid, 15 mg zinc, 2 mg copper, 65 μg selenium, 800 μg RE vitamin A, 1.4 mg vitamin B1, 1.4 mg vitamin B2, 18 mg niacin, 1.9 mg vitamin B6, 2.6 μg vitamin B12, 70 mg vitamin C, 5 μg vitamin D, 10 mg vitamin E and 150 μg iodine). Each tablet is small (approximately 10 mm diameter) and has been procured using the UNICEF supply catalogue. A single MMN supplementation dose will consist of a single tablet.
Other Name: UNICEF, Micronutrient tabs, pregnancy/PAC-1000
arm group label: Multiple micronutrients (UNIMMAP composition)
criteria: 
gender: Female
gender based: Yes
minimum age: 15 Years
maximum age: 25 Years
healthy volunteers: No
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University
investigator full name: Dr Zulfiqar Ahmed Bhutta
investigator title: Founding Chair, Centre of Excellence in Women and Child Health
mesh term: Micronutrients
mesh term: Trace Elements
sharing ipd: Yes
ipd description: Please contact the Primary Investigator directly for more details.