Clinical trial NCT01562379: Complementary Food Supplements for Reducing Childhood Undernutrition
Official title: Evaluation of Complementary Food Supplements For Reducing Childhood Undernutrition: The JiVitA-4 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stunting
Wasting
Keywords: complementary food supplements
stunting
wasting
growth
Bangladesh
infant feeding
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: United Nations World Food Programme (WFP)
name: DSM Ltd
First posted: 2012-03-23
Enrollment: 5449
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Infants 6 months of age

Primary outcomes:
measure: Stunting in Children at 18 mo
timeFrame: 18 months of age
Secondary outcomes:
measure: Morbidity
timeFrame: weekly from 6 to 18 months of age
measure: Body Composition
timeFrame: At 6, 9 and 12 months of age
measure: Developmental Milestones
timeFrame: At 6, 12, and 18 months of age
measure: Cognitive and Motor Function
timeFrame: At 18 months of age
measure: Micronutrient Status
timeFrame: 18 months of age
measure: Intestinal Function
timeFrame: At 24 months of age
Other outcomes:
measure: Maternal Knowledge, Attitude and Practice Related to Infant and Young Child Feeding
timeFrame: At 6, 12 and 18 months of age
Locations:
city: Gaibandha
country: Bangladesh
facility: The JiVitA Project, Johns Hopkins Bangladesh
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Parul Christian, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Keith P West, DrPH
role: STUDY_DIRECTOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Rolf Klemm, DrPH
role: STUDY_DIRECTOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Alain B Labrique, PhD
role: STUDY_DIRECTOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Kerry J Schulze, PhD
role: STUDY_DIRECTOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Sucheta Mehra, MS
role: STUDY_DIRECTOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Rebecca Merrill, PhD
role: STUDY_DIRECTOR
affiliation: JiVitA
name: Abu Ahmed Shamim, MS
role: STUDY_DIRECTOR
affiliation: JiVitA
name: Hasmot Ali, MPH
role: STUDY_DIRECTOR
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Tahmeed Ahmed, PhD
role: STUDY_DIRECTOR
affiliation: WFP
name: Saskia de Pee, PhD
role: STUDY_DIRECTOR
affiliation: WFP
name: Martin Bloem, PhD
role: STUDY_DIRECTOR
affiliation: WFP
name: Monira Parveen, PhD
role: STUDY_DIRECTOR
affiliation: WFP
name: Britta Schumacher, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.