Complementary Food Supplements for Reducing Childhood Undernutrition

• 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: Johns Hopkins Bloomberg School of Public Health
• 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: March 9, 2012
• First Posted Date: March 23, 2012
• Results First Submitted Date: December 3, 2017
• Results First Posted Date: August 24, 2018
• Last Update Posted Date: August 24, 2018
• Study Start Date: September 2012
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: Complementary Food Supplements for Reducing Childhood Undernutrition
• Official Title: 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: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Stunting
• Wasting

Intervention

• 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

• 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 *

• Chowdhury ZT, Hurley KM, Campbell RK, Shaikh S, Shamim AA, Mehra S, Christian P. Novel Method for Estimating Nutrient Intakes Using a Semistructured 24-Hour Diet Recall for Infants and Young Children in Rural Bangladesh. Curr Dev Nutr. 2020 Jul 15;4(9):nzaa123. doi: 10.1093/cdn/nzaa123. eCollection 2020 Sep.
• Shaikh S, Campbell RK, Mehra S, Kabir A, Schulze KJ, Wu L, Ali H, Shamim AA, West KP, Christian P. Supplementation with Fortified Lipid-Based and Blended Complementary Foods has Variable Impact on Body Composition Among Rural Bangladeshi Children: A Cluster-Randomized Controlled Trial. J Nutr. 2020 Jul 1;150(7):1924-1932. doi: 10.1093/jn/nxaa061.
• Campbell RK, Hurley KM, Shamim AA, Shaikh S, Chowdhury ZT, Mehra S, Wu L, Christian P. Complementary Food Supplements Increase Dietary Nutrient Adequacy and Do Not Replace Home Food Consumption in Children 6-18 Months Old in a Randomized Controlled Trial in Rural Bangladesh. J Nutr. 2018 Sep 1;148(9):1484-1492. doi: 10.1093/jn/nxy136.
• Campbell RK, Schulze KJ, Shaikh S, Mehra S, Ali H, Wu L, Raqib R, Baker S, Labrique A, West KP Jr, Christian P. Biomarkers of Environmental Enteric Dysfunction Among Children in Rural Bangladesh. J Pediatr Gastroenterol Nutr. 2017 Jul;65(1):40-46. doi: 10.1097/MPG.0000000000001557.
• Campbell RK, Hurley KM, Shamim AA, Shaikh S, Chowdhury ZT, Mehra S, de Pee S, Ahmed T, West KP Jr, Christian P. Effect of complementary food supplementation on breastfeeding and home diet in rural Bangladeshi children. Am J Clin Nutr. 2016 Nov;104(5):1450-1458. Epub 2016 Sep 28.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 23, 2015): 5449
• Original Estimated Enrollment (submitted: March 22, 2012): 5320
• Actual Study Completion Date: November 2014
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Infants 6 months of age

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 8 Months (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bangladesh

Administrative Information

• NCT Number: NCT01562379
• Other Study ID Numbers: 00003703; NIFA210-38418-21732 ( Other Grant/Funding Number: USDA )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Parul Christian, Johns Hopkins Bloomberg School of Public Health
• Study Sponsor: Johns Hopkins Bloomberg School of Public Health

Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh
• United Nations World Food Programme (WFP)
• DSM Ltd

Investigators

• 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