Complementary Food Supplements for Reducing Childhood Undernutrition

NCT01562379 | Completed Phase 2 Results DMC

• 2 other identifiers: 00003703NIFA210-38418-21732
• Study Type: interventional
• Target: 5,449
• Locations: 1 country
• Sites: 1

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.

Conditions

Stunting; Wasting

Keywords

complementary food supplements; stunting; wasting; growth; Bangladesh; infant feeding

Outcome Measures

Primary Outcomes (1)

• Stunting in Children at 18 mo

  Prevalence of stunting at 18 months of age.

  18 months of age

Secondary Outcomes (6)

• Morbidity

  weekly from 6 to 18 months of age

• Body Composition

  At 6, 9 and 12 months of age

• Developmental Milestones

  At 6, 12, and 18 months of age

• Cognitive and Motor Function

  At 18 months of age

• Micronutrient Status

  18 months of age

Other Outcomes (1)

• Maternal Knowledge, Attitude and Practice Related to Infant and Young Child Feeding

  At 6, 12 and 18 months of age

Study Arms (5)

No food

NO INTERVENTION

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.

Plumpy Doz

ACTIVE COMPARATOR

In this control arm children will receive prepackaged, lipid-based Plumpy'Doz (Nutriset, Mulaunay, France) for daily consumption as a snack.

Dietary Supplement: Plumpy Doz

Wheat Soy Blend (WSB++)

EXPERIMENTAL

Children will receive a WFP-developed Wheat-Soy Blend (WSB++) snack to be consumed daily.

Dietary Supplement: Wheat Soy Blend (WSB++)

Chickpea based complementary food supplement

EXPERIMENTAL

Children will receive a Chickpea based complementary food supplement to be consumed daily.

Dietary Supplement: Chickpea based complementary food supplement

Rice based complementary food supplement

EXPERIMENTAL

Children will receive a locally developed rice based complementary food supplement.

Dietary Supplement: Rice based complementary food supplement

Interventions

Wheat Soy Blend (WSB++) DIETARY_SUPPLEMENT

A wheat formulation containing protein from milk solids and soybeans, essential fats and sugar to provide optimal caloric density, and added vitamins and minerals.

Wheat Soy Blend (WSB++)

Chickpea based complementary food supplement DIETARY_SUPPLEMENT

A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals.

Chickpea based complementary food supplement

Rice based complementary food supplement DIETARY_SUPPLEMENT

Locally developed rice based complementary food with and added vitamins and minerals.

Rice based complementary food supplement

Plumpy Doz DIETARY_SUPPLEMENT

Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals.

Plumpy Doz

Eligibility Criteria

• Age: 6 Months - 8 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants 6 months of age

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• United Nations World Food Programme (WFP): collaborator
• DSM Ltd: collaborator

Study Sites (1)

The JiVitA Project, Johns Hopkins Bangladesh

Gaibandha, Bangladesh

Location

Related Publications (6)

• Pasqualino MM, Campbell RK, Hurley KM, Wu LS, Shamim AA, Shaikh S, de Pee S, Christian P. Complementary Food Supplements Fill Energy and Protein Gaps among Children with Dietary Inadequacy in a Complementary Feeding Trial in Rural Bangladesh. J Nutr. 2025 Feb;155(2):602-611. doi: 10.1016/j.tjnut.2024.12.001. Epub 2024 Dec 9.

  PMID: 39662676 DERIVED

• 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.

  PMID: 32875267 DERIVED

• 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.

  PMID: 32240304 DERIVED

• 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.

  PMID: 30184222 DERIVED

• 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.

  PMID: 28644348 DERIVED

• 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. doi: 10.3945/ajcn.116.135509. Epub 2016 Sep 28.

  PMID: 27680994 DERIVED

MeSH Terms

Conditions

Growth Disorders; Cachexia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Thinness

Results Point of Contact

• Title: Parul Christian
• Organization: Johns Hopkins Bloomberg School of Public Health

pchrist1@jhu.edu

1-410-955-1188

Study Officials

• Parul Christian, DrPH

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: March 23, 2012
• Study Start: September 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 24, 2018
• Results First Posted: August 24, 2018

Record last verified: 2017-12

Locations

BA (1)