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Complementary Food Supplements for Reducing Childhood Undernutrition

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ClinicalTrials.gov Identifier: NCT01562379
Recruitment Status : Completed
First Posted : March 23, 2012
Results First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Collaborators:
International Centre for Diarrhoeal Disease Research, Bangladesh
United Nations World Food Programme (WFP)
DSM Ltd
Information provided by (Responsible Party):
Parul Christian, Johns Hopkins Bloomberg School of Public Health

Tracking Information
First Submitted Date  ICMJE March 9, 2012
First Posted Date  ICMJE March 23, 2012
Results First Submitted Date  ICMJE December 3, 2017
Results First Posted Date  ICMJE August 24, 2018
Last Update Posted Date August 24, 2018
Study Start Date  ICMJE September 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2017)
Stunting in Children at 18 mo [ Time Frame: 18 months of age ]
Prevalence of stunting at 18 months of age.
Original Primary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
Stunting and wasting [ Time Frame: Change from 6 months to 18 months of age ]
Change in length-for-age and weight-for-length Z scores and the prevalence of stunting and wasting at 18 months of age.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2014)
  • Morbidity [ Time Frame: weekly from 6 to 18 months of age ]
    weekly morbidity will be assessed for a year and episodes of diarrhea, dysentery ALRI, and fever will be recorded.
  • Body Composition [ Time Frame: At 6, 9 and 12 months of age ]
    Bioelectrical impedance analysis will be used to look at body composition changes from baseline until 18 months of age
  • Developmental Milestones [ Time Frame: At 6, 12, and 18 months of age ]
    Age-specific developmental milestones will be assessed
  • Cognitive and Motor Function [ Time Frame: At 18 months of age ]
    Using Bayley III
  • Micronutrient Status [ Time Frame: 18 months of age ]
    Iron, vitamin A, zinc and other micronutrient status of children will be examined by intervention group.
  • Intestinal Function [ Time Frame: At 24 months of age ]
    Intestinal function using L:M and other biomarkers will be assessed by intervention group and its association with child growth
Original Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
  • Morbidity [ Time Frame: weekly from 6 to 18 months of age ]
    weekly morbidity will be assessed for a year and episodes of diarrhea, dysentery ALRI, and fever will be recorded.
  • Body Composition [ Time Frame: At 6, 9 and 12 months of age ]
    Bioelectrical impedance analysis will be used to look at body composition changes from baseline until 18 months of age
  • Developmental Milestones [ Time Frame: At 6, 12, and 18 months of age ]
    Age-specific developmental milestones will be assessed
  • Cognitive and Motor Function [ Time Frame: At 18 months of age ]
    Using Bayley III
Current Other Pre-specified Outcome Measures
 (submitted: August 22, 2014)
Maternal Knowledge, Attitude and Practice Related to Infant and Young Child Feeding [ Time Frame: At 6, 12 and 18 months of age ]
Maternal KAP
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Complementary Food Supplements for Reducing Childhood Undernutrition
Official Title  ICMJE Evaluation of Complementary Food Supplements For Reducing Childhood Undernutrition: The JiVitA-4 Study
Brief Summary The purpose of this study is to test the impact on child growth of three specially formulated complementary food supplements vs. Plumpy'Doz, a previously tested, commercially available complementary food, and vs. a control group that receives no food. All groups will receive nutrition education related to infant and young child feeding. This will be a cluster-randomised trial in children 6-18 months old in rural Rangpur and Gaibandha in Bangladesh.
Detailed Description

Childhood stunting and growth faltering is highly prevalent in South Asia. Among other strategies, adequate complementary feeding practices and provision of complementary foods that are appropriate and fill the nutrient gap by providing macro and micronutrients essential for growth are important means to reduce the global burden of undernutrition and related morbidity and mortality.

We propose to evaluate the impact of three complementary food supplement products that are fortified with micronutrients in a rural, remote setting in Bangladesh, where high rates of childhood undernutrition persist on child growth, health, and development. The three foods being tested are an enhanced wheat-soy blend (WSB++) developed by WFP, and locally developed chickpea-based and a rice-based complementary food supplements.

We will assess the impact of feeding these daily against the non-fed controls, hypothesizing that the children fed these foods show increased length for age Z scores (LAZ) and weight for length age Z scores (WLZ) of >0.21 and decreased prevalence of stunting and wasting by >10%. We expect that the impact of the three foods will be equivalent/ non-inferior to that of Plumpy'Doz.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Stunting
  • Wasting
Intervention  ICMJE
  • Dietary Supplement: Wheat Soy Blend (WSB++)
    A wheat formulation containing protein from milk solids and soybeans, essential fats and sugar to provide optimal caloric density, and added vitamins and minerals.
  • Dietary Supplement: Chickpea based complementary food supplement
    A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals.
  • Dietary Supplement: Rice based complementary food supplement
    Locally developed rice based complementary food with and added vitamins and minerals.
  • Dietary Supplement: Plumpy Doz
    Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals.
Study Arms  ICMJE
  • No Intervention: No food
    A control in which mothers will receive nutrition education about continued breastfeeding and adequate complementary feeding throughout the period of 6-18 months of age.
  • Active Comparator: Plumpy Doz
    In this control arm children will receive prepackaged, lipid-based Plumpy'Doz (Nutriset, Mulaunay, France) for daily consumption as a snack.
    Intervention: Dietary Supplement: Plumpy Doz
  • Experimental: Wheat Soy Blend (WSB++)
    Children will receive a WFP-developed Wheat-Soy Blend (WSB++) snack to be consumed daily.
    Intervention: Dietary Supplement: Wheat Soy Blend (WSB++)
  • Experimental: Chickpea based complementary food supplement
    Children will receive a Chickpea based complementary food supplement to be consumed daily.
    Intervention: Dietary Supplement: Chickpea based complementary food supplement
  • Experimental: Rice based complementary food supplement
    Children will receive a locally developed rice based complementary food supplement.
    Intervention: Dietary Supplement: Rice based complementary food supplement
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2015)
5449
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2012)
5320
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infants 6 months of age
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 8 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01562379
Other Study ID Numbers  ICMJE 00003703
NIFA210-38418-21732 ( Other Grant/Funding Number: USDA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Parul Christian, Johns Hopkins Bloomberg School of Public Health
Study Sponsor  ICMJE Johns Hopkins Bloomberg School of Public Health
Collaborators  ICMJE
  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • United Nations World Food Programme (WFP)
  • DSM Ltd
Investigators  ICMJE
Principal Investigator: Parul Christian, DrPH Johns Hopkins Bloomberg School of Public Health
Study Director: Keith P West, DrPH Johns Hopkins Bloomberg School of Public Health
Study Director: Rolf Klemm, DrPH Johns Hopkins Bloomberg School of Public Health
Study Director: Alain B Labrique, PhD Johns Hopkins Bloomberg School of Public Health
Study Director: Kerry J Schulze, PhD Johns Hopkins Bloomberg School of Public Health
Study Director: Sucheta Mehra, MS Johns Hopkins Bloomberg School of Public Health
Study Director: Rebecca Merrill, PhD Johns Hopkins Bloomberg School of Public Health
Study Director: Abu Ahmed Shamim, MS JiVitA
Study Director: Hasmot Ali, MPH JiVitA
Study Director: Tahmeed Ahmed, PhD International Centre for Diarrhoeal Disease Research, Bangladesh
Study Director: Saskia de Pee, PhD WFP
Study Director: Martin Bloem, PhD WFP
Study Director: Monira Parveen, PhD WFP
Study Director: Britta Schumacher, PhD WFP
PRS Account Johns Hopkins Bloomberg School of Public Health
Verification Date December 2017

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