<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/NCT02257762</url>
  </required_header>
  <id_info>
    <org_study_id>LNS-CAMB-INFANTS-EFF</org_study_id>
    <nct_id>NCT02257762</nct_id>
  </id_info>
  <brief_title>Efficacy of a Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement for Children Under Two in Cambodia</brief_title>
  <official_title>Efficacy of a Locally-Produced Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement (LNS) for Children Under Two Years in Cambodia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Recherche pour le Developpement, Cambodia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UNICEF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Fisheries Post-harvest Technologies and Quality Control</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut de Recherche pour le Developpement, Cambodia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this trial is to evaluate the efficacy of the LNS on children aged 6-17 months&#xD;
      in preventing growth faltering and improving micronutrient status. The impact of product will&#xD;
      be compared to Corn Soy Blend ++ (CSB++), Sprinkles, and to a control group consuming an&#xD;
      unsupplemented diet, which is usually borbor at an early age, and thereafter, family foods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND:&#xD;
&#xD;
      In Cambodia, progress in combatting malnutrition has stalled. In 2010, 40% of all children&#xD;
      under five (and 49% of 4-5 year-olds) were stunted, 11% were wasted, and 28% were&#xD;
      underweight, indicating, respectively, chronic and acute malnutrition, and a combination of&#xD;
      the two. Stunting is partially attributed to poor complementary feeding, which remains&#xD;
      inadequate for achieving growth outcomes and micronutrient status.&#xD;
&#xD;
      Malnutrition can be prevented with supplementary foods. These foods usually contain a source&#xD;
      of protein and lipids such as powered milk, soy or peanuts, and multiple micronutrients. They&#xD;
      can be prepared as a fortified blended product, such as Corn-Soy Blend++ (CSB++), that is&#xD;
      mixed with water to make a porridge, or ready-to-use supplementary foods (RUSFs). The latter&#xD;
      are usually lipid-based nutrient supplements (LNSs) which are often pastes such as the&#xD;
      peanut-based Plumpy'Nut™. These energy-dense supplementary foods contain both macro and&#xD;
      micronutrients and are used to prevent and treat moderate acute malnutrition by promoting&#xD;
      improved linear growth, weight gain and micronutrient status among children. Until recently,&#xD;
      treatment of moderate acute malnutrition has relied on fortified blended products. The new&#xD;
      RUSFs are also proving effective, as they are higher energy and have a longer shelf life, and&#xD;
      since they require no preparation, are convenient. Another common nutrition intervention is&#xD;
      multiple micronutrient supplements such as Sprinkles. These are individually-packed powders&#xD;
      that can be added to food. However, micronutrients are more likely to achieve growth outcomes&#xD;
      when they are combined with energy, for example, in lipid-based nutrient supplements and&#xD;
      there is no evidence that micronutrient powders alone contribute to growth.&#xD;
&#xD;
      Until June 2014, the United Nations World Food Program (WFP) used CSB++ (now called&#xD;
      Supercereal Plus) to treat and prevent moderate acute malnutrition in Cambodia. Sprinkles are&#xD;
      also being distributed, though not widely, to prevent micronutrient deficiencies. These&#xD;
      products that have been recently or are currently used are relatively expensive to procure&#xD;
      and ship to Cambodia and in the case of Sprinkles, are not as effective as foods that contain&#xD;
      macronutrients. Moreover, CSB++ was not very well accepted in practice, and WFP has phased it&#xD;
      out. Therefore, UNICEF and the Cambodian Ministry of Health are looking for a&#xD;
      locally-produced product containing macro and micronutrients to prevent growth faltering and&#xD;
      improve micronutrient status in Cambodian children.&#xD;
&#xD;
      TRIAL DESIGN AND METHODOLOGY:&#xD;
&#xD;
      Therefore, this trial will evaluate the efficacy of the LNS on children aged 6-17 months in&#xD;
      preventing growth faltering and improving micronutrient statu. The impact of product will be&#xD;
      compared to CSB++, Sprinkles, and to a control group.&#xD;
&#xD;
      The trial is a prospective, cluster randomised, non-blinded controlled trial among infants&#xD;
      6-17 months of age. The trial aims to establish the superiority of the novel LNS, using CSB++&#xD;
      and Sprinkles as active comparators and the unimproved diet as a control. The allocation&#xD;
      ratio is 1:1. The study will take place over 8 months.&#xD;
&#xD;
      The study will be conducted in 28 sites in peri-urban Phnom Penh. Infants aged 6-12 months&#xD;
      will be recruited. Upon consent and enrolment, baseline data will be collected from the&#xD;
      participants. This will include demographics, morbidity, anthropometry (weight, height,&#xD;
      mid-upper arm circumference, skinfolds), haematological and stool samples, dietary data&#xD;
      (breastfeeding, food frequency and dietary diversity). Data will be collected monthly, and&#xD;
      haematological samples will be collected again at endline.&#xD;
&#xD;
      Participants will then be provided with a one month supply of the food to which their site&#xD;
      has been allocated. Staff will explain how to prepare the food, how often it should be&#xD;
      consumed, and who should consume it (i.e. subjects). Participants will be provided with food&#xD;
      on a monthly basis. They will continue to consume the food over a six-month period, at which&#xD;
      time endline data, including haematological samples, will be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2016</start_date>
  <completion_date type="Anticipated">October 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nutritional status</measure>
    <time_frame>6 months</time_frame>
    <description>Weight-for-height (WHZ), length/height-for-age (L/HAZ), and weight-for-age (WAZ) calculated through monthly weight and height measurements</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>6 months</time_frame>
    <description>Triceps, biceps and/or subscapular skinfolds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iron status</measure>
    <time_frame>6 months</time_frame>
    <description>Analysis of haemoglobin (g/l), ferritin (µg/l), tranferrin receptor (mg/l), C reactive protein (mg/l), and alpha-1-acid glycoprotein (mg/l)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">487</enrollment>
  <condition>Child Malnutrition</condition>
  <arm_group>
    <arm_group_label>Lipid-based nutrient supplement (LNS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LNS added to borbor, eaten over 6 months, age 6-12 months to age 11-17 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Corn-soy blend ++ (CSB++)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CSB++ porridge, eaten over 6 months, age 6-12 months to age 11-17 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sprinkles</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sprinkles added to borbor, eaten over 6 months, age 6-12 months to age 11-17 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Plain borbor and thereafter family foods, eaten over 6 months, age 6-12 months to age 11-17 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>LNS</intervention_name>
    <description>Compact, paste-filled wafer snack containing fish, rice, soy, mungbeans, oil, sugar and multiple micronutrients</description>
    <arm_group_label>Lipid-based nutrient supplement (LNS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Corn-soy blend ++ (CSB++)</intervention_name>
    <description>Blended flour containing soy, corn, milk powder, oil, sugar and multiple micronutrients.</description>
    <arm_group_label>Corn-soy blend ++ (CSB++)</arm_group_label>
    <other_name>Supercereal Plus</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sprinkles</intervention_name>
    <description>Multiple micronutrient powder packaged in sachet.</description>
    <arm_group_label>Sprinkles</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 6-12 months&#xD;
&#xD;
          -  Normally nourished or only moderately malnourished (MUAC&gt;115mm, WHZ score&gt;-3)&#xD;
&#xD;
          -  Have not received therapy for acute malnutrition within one month prior to&#xD;
             presentation&#xD;
&#xD;
          -  Healthy (no ill-health in past two weeks)&#xD;
&#xD;
          -  Anaemia status - normal, mild or moderate&#xD;
&#xD;
          -  No known food intolerances&#xD;
&#xD;
          -  Informed signed consent of caregiver&#xD;
&#xD;
          -  Caregivers are healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children &lt;6 months or &gt;12mths&#xD;
&#xD;
          -  Severely malnourished (MUAC&lt; 115mm, WHZ score&lt;3, bipedal pitting oedema).&#xD;
&#xD;
          -  Have received therapy for acute malnutrition within one month prior to presentation&#xD;
&#xD;
          -  Any medical complications at the recruitment time or illness requiring referral or&#xD;
             clinic visit in past 2 weeks&#xD;
&#xD;
          -  Severe anaemia (Hb&lt;70g/l)&#xD;
&#xD;
          -  Known intolerances&#xD;
&#xD;
          -  No informed signed consent of caregiver&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frank T Wieringa, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>IRD</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bindi Borg, MA,PhD cand.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sydney</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IRD Cambodia</name>
      <address>
        <city>Phnom Penh</city>
        <country>Cambodia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Cambodia</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>September 13, 2016</last_update_submitted>
  <last_update_submitted_qc>September 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sydney</investigator_affiliation>
    <investigator_full_name>Bindi Borg</investigator_full_name>
    <investigator_title>PhD Candidate</investigator_title>
  </responsible_party>
  <keyword>Ready-to-use supplementary food (RUSF)</keyword>
  <keyword>Lipid-based nutrient supplement (LNS)</keyword>
  <keyword>Multiple micronutrients (MMN)</keyword>
  <keyword>Complementary feeding</keyword>
  <keyword>Home fortification</keyword>
  <keyword>Efficacy/impact</keyword>
  <keyword>Infant and young child feeding (IYCF)</keyword>
  <keyword>Cambodia</keyword>
  <keyword>Cluster randomised controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Child Nutrition Disorders</mesh_term>
  </condition_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/NCT02257762
org study id: LNS-CAMB-INFANTS-EFF
nct id: NCT02257762
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this trial is to evaluate the efficacy of the LNS on children aged 6-17 months
      in preventing growth faltering and improving micronutrient status. The impact of product will
      be compared to Corn Soy Blend ++ (CSB++), Sprinkles, and to a control group consuming an
      unsupplemented diet, which is usually borbor at an early age, and thereafter, family foods.
BACKGROUND:

      In Cambodia, progress in combatting malnutrition has stalled. In 2010, 40% of all children
      under five (and 49% of 4-5 year-olds) were stunted, 11% were wasted, and 28% were
      underweight, indicating, respectively, chronic and acute malnutrition, and a combination of
      the two. Stunting is partially attributed to poor complementary feeding, which remains
      inadequate for achieving growth outcomes and micronutrient status.

      Malnutrition can be prevented with supplementary foods. These foods usually contain a source
      of protein and lipids such as powered milk, soy or peanuts, and multiple micronutrients. They
      can be prepared as a fortified blended product, such as Corn-Soy Blend++ (CSB++), that is
      mixed with water to make a porridge, or ready-to-use supplementary foods (RUSFs). The latter
      are usually lipid-based nutrient supplements (LNSs) which are often pastes such as the
      peanut-based Plumpy'Nut™. These energy-dense supplementary foods contain both macro and
      micronutrients and are used to prevent and treat moderate acute malnutrition by promoting
      improved linear growth, weight gain and micronutrient status among children. Until recently,
      treatment of moderate acute malnutrition has relied on fortified blended products. The new
      RUSFs are also proving effective, as they are higher energy and have a longer shelf life, and
      since they require no preparation, are convenient. Another common nutrition intervention is
      multiple micronutrient supplements such as Sprinkles. These are individually-packed powders
      that can be added to food. However, micronutrients are more likely to achieve growth outcomes
      when they are combined with energy, for example, in lipid-based nutrient supplements and
      there is no evidence that micronutrient powders alone contribute to growth.

      Until June 2014, the United Nations World Food Program (WFP) used CSB++ (now called
      Supercereal Plus) to treat and prevent moderate acute malnutrition in Cambodia. Sprinkles are
      also being distributed, though not widely, to prevent micronutrient deficiencies. These
      products that have been recently or are currently used are relatively expensive to procure
      and ship to Cambodia and in the case of Sprinkles, are not as effective as foods that contain
      macronutrients. Moreover, CSB++ was not very well accepted in practice, and WFP has phased it
      out. Therefore, UNICEF and the Cambodian Ministry of Health are looking for a
      locally-produced product containing macro and micronutrients to prevent growth faltering and
      improve micronutrient status in Cambodian children.

      TRIAL DESIGN AND METHODOLOGY:

      Therefore, this trial will evaluate the efficacy of the LNS on children aged 6-17 months in
      preventing growth faltering and improving micronutrient statu. The impact of product will be
      compared to CSB++, Sprinkles, and to a control group.

      The trial is a prospective, cluster randomised, non-blinded controlled trial among infants
      6-17 months of age. The trial aims to establish the superiority of the novel LNS, using CSB++
      and Sprinkles as active comparators and the unimproved diet as a control. The allocation
      ratio is 1:1. The study will take place over 8 months.

      The study will be conducted in 28 sites in peri-urban Phnom Penh. Infants aged 6-12 months
      will be recruited. Upon consent and enrolment, baseline data will be collected from the
      participants. This will include demographics, morbidity, anthropometry (weight, height,
      mid-upper arm circumference, skinfolds), haematological and stool samples, dietary data
      (breastfeeding, food frequency and dietary diversity). Data will be collected monthly, and
      haematological samples will be collected again at endline.

      Participants will then be provided with a one month supply of the food to which their site
      has been allocated. Staff will explain how to prepare the food, how often it should be
      consumed, and who should consume it (i.e. subjects). Participants will be provided with food
      on a monthly basis. They will continue to consume the food over a six-month period, at which
      time endline data, including haematological samples, will be collected.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Nutritional status
time frame: 6 months
description: Weight-for-height (WHZ), length/height-for-age (L/HAZ), and weight-for-age (WAZ) calculated through monthly weight and height measurements
measure: Body composition
time frame: 6 months
description: Triceps, biceps and/or subscapular skinfolds
measure: Iron status
time frame: 6 months
description: Analysis of haemoglobin (g/l), ferritin (µg/l), tranferrin receptor (mg/l), C reactive protein (mg/l), and alpha-1-acid glycoprotein (mg/l)
arm group label: Lipid-based nutrient supplement (LNS)
arm group type: Experimental
description: LNS added to borbor, eaten over 6 months, age 6-12 months to age 11-17 months
arm group label: Corn-soy blend ++ (CSB++)
arm group type: Active Comparator
description: CSB++ porridge, eaten over 6 months, age 6-12 months to age 11-17 months
arm group label: Sprinkles
arm group type: Active Comparator
description: Sprinkles added to borbor, eaten over 6 months, age 6-12 months to age 11-17 months
arm group label: Control
arm group type: No Intervention
description: Plain borbor and thereafter family foods, eaten over 6 months, age 6-12 months to age 11-17 months
intervention type: Dietary Supplement
intervention name: LNS
description: Compact, paste-filled wafer snack containing fish, rice, soy, mungbeans, oil, sugar and multiple micronutrients
arm group label: Lipid-based nutrient supplement (LNS)
intervention type: Dietary Supplement
intervention name: Corn-soy blend ++ (CSB++)
description: Blended flour containing soy, corn, milk powder, oil, sugar and multiple micronutrients.
arm group label: Corn-soy blend ++ (CSB++)
other name: Supercereal Plus
intervention type: Dietary Supplement
intervention name: Sprinkles
description: Multiple micronutrient powder packaged in sachet.
arm group label: Sprinkles
criteria: 
gender: All
minimum age: 6 Months
maximum age: 12 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Frank T Wieringa, MD, PhD
role: Study Director
affiliation: IRD
last name: Bindi Borg, MA,PhD cand.
role: Principal Investigator
affiliation: University of Sydney
facility: 
country: Cambodia
responsible party type: Principal Investigator
investigator affiliation: University of Sydney
investigator full name: Bindi Borg
investigator title: PhD Candidate
mesh term: Malnutrition
mesh term: Child Nutrition Disorders