Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NIFA210-38418-21732 | Other Grant/Funding Number | USDA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
| United Nations World Food Programme (WFP) | OTHER |
| DSM Ltd | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Wheat Soy Blend (WSB++) | Experimental | Children will receive a WFP-developed Wheat-Soy Blend (WSB++) snack to be consumed daily. |
|
| Chickpea based complementary food supplement | Experimental | Children will receive a Chickpea based complementary food supplement to be consumed daily. |
|
| Rice based complementary food supplement | Experimental | Children will receive a locally developed rice based complementary food supplement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Stunting in Children at 18 mo | Prevalence of stunting at 18 months of age. | 18 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | weekly morbidity will be assessed for a year and episodes of diarrhea, dysentery ALRI, and fever will be recorded. | weekly from 6 to 18 months of age |
| Body Composition | Bioelectrical impedance analysis will be used to look at body composition changes from baseline until 18 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Knowledge, Attitude and Practice Related to Infant and Young Child Feeding | Maternal KAP | At 6, 12 and 18 months of age |
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The JiVitA Project, Johns Hopkins Bangladesh | Gaibandha | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39662676 | Derived | 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. | |
| 32875267 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Plumpy Doz | In this control arm children will receive prepackaged, lipid-based Plumpy'Doz (Nutriset, Mulaunay, France) for daily consumption as a snack. Plumpy Doz: Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals. |
| FG002 | Wheat Soy Blend (WSB++) | Children will receive a WFP-developed Wheat-Soy Blend (WSB++) snack to be consumed daily. 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. |
| FG003 | Chickpea Based Complementary Food Supplement | Children will receive a Chickpea based complementary food supplement to be consumed daily. Chickpea based complementary food supplement: A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals. |
| FG004 | Rice Based Complementary Food Supplement | Children will receive a locally developed rice based complementary food supplement. Rice based complementary food supplement: Locally developed rice based complementary food with and added vitamins and minerals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Plumpy Doz |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stunting in Children at 18 mo | Prevalence of stunting at 18 months of age. | Children followed after 1 year of supplementation from 6 months at 18 months of age | Posted | Count of Participants | Participants | 18 months of age |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Parul Christian | Johns Hopkins Bloomberg School of Public Health | 1-410-955-1188 | pchrist1@jhu.edu |
Not provided
| ID | Term |
|---|---|
| D006130 | Growth Disorders |
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Chickpea based complementary food supplement | Dietary Supplement | A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals. |
|
| Rice based complementary food supplement | Dietary Supplement | Locally developed rice based complementary food with and added vitamins and minerals. |
|
| Plumpy Doz | Dietary Supplement | Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals. |
|
| At 6, 9 and 12 months of age |
| Developmental Milestones | Age-specific developmental milestones will be assessed | At 6, 12, and 18 months of age |
| Cognitive and Motor Function | Using Bayley III | At 18 months of age |
| Micronutrient Status | Iron, vitamin A, zinc and other micronutrient status of children will be examined by intervention group. | 18 months of age |
| Intestinal Function | Intestinal function using L:M and other biomarkers will be assessed by intervention group and its association with child growth | At 24 months of age |
| 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 |
| 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. |
| 32240304 | 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. |
| 30184222 | 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. |
| 28644348 | 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. |
| 27680994 | 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. |
In this control arm children will receive prepackaged, lipid-based Plumpy'Doz (Nutriset, Mulaunay, France) for daily consumption as a snack.
Plumpy Doz: Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals.
| BG002 | Wheat Soy Blend (WSB++) | Children will receive a WFP-developed Wheat-Soy Blend (WSB++) snack to be consumed daily. 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. |
| BG003 | Chickpea Based Complementary Food Supplement | Children will receive a Chickpea based complementary food supplement to be consumed daily. Chickpea based complementary food supplement: A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals. |
| BG004 | Rice Based Complementary Food Supplement | Children will receive a locally developed rice based complementary food supplement. Rice based complementary food supplement: Locally developed rice based complementary food with and added vitamins and minerals. |
| BG005 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Wheat Soy Blend (WSB++) | Children will receive a WFP-developed Wheat-Soy Blend (WSB++) snack to be consumed daily. 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. |
| OG003 | Chickpea Based Complementary Food Supplement | Children will receive a Chickpea based complementary food supplement to be consumed daily. Chickpea based complementary food supplement: A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals. |
| OG004 | Rice Based Complementary Food Supplement | Children will receive a locally developed rice based complementary food supplement. Rice based complementary food supplement: Locally developed rice based complementary food with and added vitamins and minerals. |
|
|
| Secondary | Morbidity | weekly morbidity will be assessed for a year and episodes of diarrhea, dysentery ALRI, and fever will be recorded. | Not Posted | weekly from 6 to 18 months of age | Participants |
| Secondary | Body Composition | Bioelectrical impedance analysis will be used to look at body composition changes from baseline until 18 months of age | Not Posted | At 6, 9 and 12 months of age | Participants |
| Secondary | Developmental Milestones | Age-specific developmental milestones will be assessed | Not Posted | At 6, 12, and 18 months of age | Participants |
| Secondary | Cognitive and Motor Function | Using Bayley III | Not Posted | At 18 months of age | Participants |
| Secondary | Micronutrient Status | Iron, vitamin A, zinc and other micronutrient status of children will be examined by intervention group. | Not Posted | 18 months of age | Participants |
| Secondary | Intestinal Function | Intestinal function using L:M and other biomarkers will be assessed by intervention group and its association with child growth | Not Posted | At 24 months of age | Participants |
| Other Pre-specified | Maternal Knowledge, Attitude and Practice Related to Infant and Young Child Feeding | Maternal KAP | Not Posted | At 6, 12 and 18 months of age | Participants |
| 12 |
| 1,438 |
| 0 |
| 1,438 |
| 0 |
| 1,438 |
| EG001 | Plumpy Doz | In this control arm children will receive prepackaged, lipid-based Plumpy'Doz (Nutriset, Mulaunay, France) for daily consumption as a snack. Plumpy Doz: Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals. | 9 | 1,492 | 0 | 1,492 | 0 | 1,492 |
| EG002 | Wheat Soy Blend (WSB++) | Children will receive a WFP-developed Wheat-Soy Blend (WSB++) snack to be consumed daily. 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. | 8 | 851 | 0 | 864 | 0 | 851 |
| EG003 | Chickpea Based Complementary Food Supplement | Children will receive a Chickpea based complementary food supplement to be consumed daily. Chickpea based complementary food supplement: A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals. | 6 | 843 | 0 | 860 | 0 | 843 |
| EG004 | Rice Based Complementary Food Supplement | Children will receive a locally developed rice based complementary food supplement. Rice based complementary food supplement: Locally developed rice based complementary food with and added vitamins and minerals. | 2 | 825 | 0 | 838 | 0 | 825 |
Not provided
Not provided
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013851 | Thinness |