<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/NCT03287882</url>
  </required_header>
  <id_info>
    <org_study_id>4324-Ped-ERC-16</org_study_id>
    <nct_id>NCT03287882</nct_id>
  </id_info>
  <brief_title>Effect of Micronutrients and Life Skills Education on the Health and Nutrition of Adolescent and Young Women in Pakistan</brief_title>
  <official_title>Prospective, Cluster Randomized Effectiveness Trial of Multiple Micronutrient Supplementation and Life Skills Education Provided From Preconception on Health and Nutrition Outcomes of Young, Reproductive-age Pakistani Women (15-24 Years)</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>National Program for Family Planning and Primary Health Care</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bill and Melinda Gates Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aga Khan University</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 primary aims of this study are: 1) To evaluate the impact of supplementation with&#xD;
      multiple micronutrients (MMN) from preconception and life skills education among women&#xD;
      15-18.9 years of age at enrolment on the prevalence of anemia in a population setting; and 2)&#xD;
      To evaluate the impact of supplementation with MMN from preconception and life skills&#xD;
      education among young women 15-24 years of age on the rate of low birth weight (LBW) in a&#xD;
      population setting. Infants born to mothers enrolled in the study will be followed for 1&#xD;
      year. This study aims to enrol 25,400 non-pregnant young women in Matiari district. This&#xD;
      sample size is anticipated to equate to 1456 births. Participants will be randomized by&#xD;
      cluster to receive either MMN supplements and life skills education or the standard of care&#xD;
      at enrolment. Clusters have been defined based on health facility catchment areas. MMN&#xD;
      supplements will be provided twice weekly during the preconception period, once daily during&#xD;
      the pregnancy period, and once daily until 6 months after giving birth during the postpartum&#xD;
      period; and a package of life skills education materials will be provided bi-monthly during&#xD;
      the preconception period. In addition to the primary outcomes, measurements will include&#xD;
      micronutrient status, anthropometrics, birth outcomes, dietary intake and feeding practices,&#xD;
      adherence, and indices of empowerment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 30, 2017</start_date>
  <completion_date type="Anticipated">February 2022</completion_date>
  <primary_completion_date type="Actual">March 12, 2021</primary_completion_date>
  <phase>Phase 3</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>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Some investigators are blinded to the allocation of the intervention, and all study data collectors are blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Anemia status</measure>
    <time_frame>0, 12*, 24 months (*in subgroup only)</time_frame>
    <description>Hemoglobin concentration &lt;12 g/dL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Low birth weight</measure>
    <time_frame>At birth</time_frame>
    <description>Birth weight &lt;2500 g</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biomarkers: serum ferritin, serum transferrin receptor, hepcidin, serum retinol, serum 25(OH)D, alpha-glycolytic protein, C-reactive protein (women)</measure>
    <time_frame>Preconception (subgroup only): enrolment, 1 year, 2 years; Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometrics: height (women)</measure>
    <time_frame>Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometrics: middle upper arm circumference (women)</measure>
    <time_frame>Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometrics: weight (women)</measure>
    <time_frame>Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gestational age</measure>
    <time_frame>At birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preterm birth</measure>
    <time_frame>At birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stillbirth</measure>
    <time_frame>At birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Small for gestational age</measure>
    <time_frame>At birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth size: length</measure>
    <time_frame>Within 24 hours of birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth size: head circumference</measure>
    <time_frame>Within 24 hours of birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth size: middle upper arm circumference</measure>
    <time_frame>Within 24 hours of birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth size: weight</measure>
    <time_frame>Within 24 hours of birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth defects</measure>
    <time_frame>At birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant growth: length</measure>
    <time_frame>1, 3, 6, 9, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant growth: head circumference</measure>
    <time_frame>1, 3, 6, 9, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant growth: middle upper arm circumference</measure>
    <time_frame>1, 3, 6, 9, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant growth: weight</measure>
    <time_frame>1, 3, 6, 9, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age at marriage</measure>
    <time_frame>Enrolment, 1 year, 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Completion of 10th grade education</measure>
    <time_frame>Enrolment, 1 year, 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of sanitary pad during last menstrual period</measure>
    <time_frame>Enrolment, 1 year, 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intake: 24-hour recall (subgroup of women)</measure>
    <time_frame>Preconception: enrolment; Pregnancy: 4-12 weeks, 32 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25447</enrollment>
  <condition>Adolescents</condition>
  <condition>Anemia</condition>
  <condition>Pregnancy</condition>
  <condition>Empowerment</condition>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Preconception period: none&#xD;
Pregnancy period: daily iron (60 mg) and folic acid (400 µg) supplementation from confirmation of pregnancy; daily balanced energy protein supplements will additionally be provided to those participants who are underweight at the confirmation of pregnancy for the duration of the pregnancy&#xD;
Postpartum period: daily iron and folic acid supplementation to 6 months postpartum</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MMN supplementation and life skills education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Preconception period: twice-weekly MMN supplementation and bi-monthly group session including life skill based education materials&#xD;
Pregnancy period: daily MMN supplementation from confirmation of pregnancy; daily balanced energy protein supplements will additionally be provided to those participants who are underweight at the confirmation of pregnancy for the duration of the pregnancy&#xD;
Postpartum period: daily MMN supplementation to 6 months postpartum</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.</description>
    <arm_group_label>MMN supplementation and life skills education</arm_group_label>
    <other_name>UNICEF, Micronutrient tabs, pregnancy/PAC-1000</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Life skills based education</intervention_name>
    <description>The life skills based education will be provided bi-monthly in the format of a group session throughout the preconception period. Three topic areas related to empowerment have been prioritized, including preventing early marriage; personal and menstrual hygiene practices; and the importance of nutrition to good health. Integrated within these topics will be messages related to the importance of continuing one's education, mental health, gender norms and equality, decision making, advocacy, resiliency, participation, communication skills, facing challenges, agency, conflict resolution, and the prevention of violence.</description>
    <arm_group_label>MMN supplementation and life skills education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Minimum age at enrolment: 15 years&#xD;
&#xD;
          -  Maximum age at enrolment: 23 years&#xD;
&#xD;
          -  Any marital status&#xD;
&#xD;
          -  Intend to comply with study intervention and follow up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women participating in other nutrition trials&#xD;
&#xD;
          -  Women who intend to leave the study area&#xD;
&#xD;
          -  Women who are already pregnant&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zulfiqar A Bhutta, PhD, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aga Khan University</affiliation>
  </overall_official>
  <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>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</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>Director, Centre of Excellence in Women and Child Health</investigator_title>
  </responsible_party>
  <keyword>preconception supplementation</keyword>
  <keyword>multiple micronutrients</keyword>
  <keyword>low birth weight</keyword>
  <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>
  <!-- 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/NCT03287882
org study id: 4324-Ped-ERC-16
nct id: NCT03287882
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary aims of this study are: 1) To evaluate the impact of supplementation with
      multiple micronutrients (MMN) from preconception and life skills education among women
      15-18.9 years of age at enrolment on the prevalence of anemia in a population setting; and 2)
      To evaluate the impact of supplementation with MMN from preconception and life skills
      education among young women 15-24 years of age on the rate of low birth weight (LBW) in a
      population setting. Infants born to mothers enrolled in the study will be followed for 1
      year. This study aims to enrol 25,400 non-pregnant young women in Matiari district. This
      sample size is anticipated to equate to 1456 births. Participants will be randomized by
      cluster to receive either MMN supplements and life skills education or the standard of care
      at enrolment. Clusters have been defined based on health facility catchment areas. MMN
      supplements will be provided twice weekly during the preconception period, once daily during
      the pregnancy period, and once daily until 6 months after giving birth during the postpartum
      period; and a package of life skills education materials will be provided bi-monthly during
      the preconception period. In addition to the primary outcomes, measurements will include
      micronutrient status, anthropometrics, birth outcomes, dietary intake and feeding practices,
      adherence, and indices of empowerment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
masking description: Some investigators are blinded to the allocation of the intervention, and all study data collectors are blinded.
measure: Anemia status
time frame: 0, 12*, 24 months (*in subgroup only)
description: Hemoglobin concentration <12 g/dL
measure: Low birth weight
time frame: At birth
description: Birth weight <2500 g
measure: Biomarkers: serum ferritin, serum transferrin receptor, hepcidin, serum retinol, serum 25(OH)D, alpha-glycolytic protein, C-reactive protein (women)
time frame: Preconception (subgroup only): enrolment, 1 year, 2 years; Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week
measure: Anthropometrics: height (women)
time frame: Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months
measure: Anthropometrics: middle upper arm circumference (women)
time frame: Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months
measure: Anthropometrics: weight (women)
time frame: Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months
measure: Gestational age
time frame: At birth
measure: Preterm birth
time frame: At birth
measure: Stillbirth
time frame: At birth
measure: Small for gestational age
time frame: At birth
measure: Birth size: length
time frame: Within 24 hours of birth
measure: Birth size: head circumference
time frame: Within 24 hours of birth
measure: Birth size: middle upper arm circumference
time frame: Within 24 hours of birth
measure: Birth size: weight
time frame: Within 24 hours of birth
measure: Birth defects
time frame: At birth
measure: Infant growth: length
time frame: 1, 3, 6, 9, 12 months
measure: Infant growth: head circumference
time frame: 1, 3, 6, 9, 12 months
measure: Infant growth: middle upper arm circumference
time frame: 1, 3, 6, 9, 12 months
measure: Infant growth: weight
time frame: 1, 3, 6, 9, 12 months
measure: Age at marriage
time frame: Enrolment, 1 year, 2 years
measure: Completion of 10th grade education
time frame: Enrolment, 1 year, 2 years
measure: Use of sanitary pad during last menstrual period
time frame: Enrolment, 1 year, 2 years
measure: Dietary intake: 24-hour recall (subgroup of women)
time frame: Preconception: enrolment; Pregnancy: 4-12 weeks, 32 weeks
arm group label: Standard of care
arm group type: No Intervention
description: Preconception period: none
Pregnancy period: daily iron (60 mg) and folic acid (400 µg) supplementation from confirmation of pregnancy; daily balanced energy protein supplements will additionally be provided to those participants who are underweight at the confirmation of pregnancy for the duration of the pregnancy
Postpartum period: daily iron and folic acid supplementation to 6 months postpartum
arm group label: MMN supplementation and life skills education
arm group type: Experimental
description: Preconception period: twice-weekly MMN supplementation and bi-monthly group session including life skill based education materials
Pregnancy period: daily MMN supplementation from confirmation of pregnancy; daily balanced energy protein supplements will additionally be provided to those participants who are underweight at the confirmation of pregnancy for the duration of the pregnancy
Postpartum period: daily MMN supplementation to 6 months postpartum
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.
arm group label: MMN supplementation and life skills education
other name: UNICEF, Micronutrient tabs, pregnancy/PAC-1000
intervention type: Behavioral
intervention name: Life skills based education
description: The life skills based education will be provided bi-monthly in the format of a group session throughout the preconception period. Three topic areas related to empowerment have been prioritized, including preventing early marriage; personal and menstrual hygiene practices; and the importance of nutrition to good health. Integrated within these topics will be messages related to the importance of continuing one's education, mental health, gender norms and equality, decision making, advocacy, resiliency, participation, communication skills, facing challenges, agency, conflict resolution, and the prevention of violence.
arm group label: MMN supplementation and life skills education
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zulfiqar A Bhutta, PhD, MBBS
role: Principal Investigator
affiliation: Aga Khan University
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University
investigator full name: Dr Zulfiqar Ahmed Bhutta
investigator title: Director, Centre of Excellence in Women and Child Health
mesh term: Micronutrients
mesh term: Trace Elements