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

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Conditions: Stunting; Wasting
• Interventions: Dietary Supplement: Wheat Soy Blend (WSB++); Dietary Supplement: Chickpea based complementary food supplement; Dietary Supplement: Rice based complementary food supplement; Dietary Supplement: Plumpy Doz
• Enrollment: 5449

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	No Food	Plumpy Doz	Wheat Soy Blend (WSB++)	Chickpea Based Complementary Food Supplement	Rice Based Complementary Food Supplement
Arm/Group Description	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.	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.	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.	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.	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.
Period Title: Overall Study
Started	1438	1492	851	843	825
Completed	1312	1395	789	786	785
Not Completed	126	97	62	57	40

Baseline Characteristics

Arm/Group Title		No Food	Plumpy Doz	Wheat Soy Blend (WSB++)	Chickpea Based Complementary Food Supplement	Rice Based Complementary Food Supplement	Total
Arm/Group Description		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.	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.	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.	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.	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.	Total of all reporting groups
Overall Number of Baseline Participants		1438	1492	851	843	825	5449
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Months
	Number Analyzed	1438 participants	1492 participants	851 participants	843 participants	825 participants	5449 participants
		6.13 (0.0)	6.26 (0.26)	6.26 (0.27)	6.24 (0.25)	6.25 (0.25)	6.23 (0.21)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1438 participants	1492 participants	851 participants	843 participants	825 participants	5449 participants
	Female	752 52.3%	725 48.6%	432 50.8%	424 50.3%	425 51.5%	2758 50.6%
	Male	686 47.7%	767 51.4%	419 49.2%	419 49.7%	400 48.5%	2691 49.4%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Bangladesh	Number Analyzed	1438 participants	1492 participants	851 participants	843 participants	825 participants	5449 participants
		1438	1492	851	843	852	5476

Outcome Measures

1. Primary Outcome

Title	Stunting in Children at 18 mo
Description	Prevalence of stunting at 18 months of age.
Time Frame	18 months of age

Outcome Measure Data

Analysis Population Description

Children followed after 1 year of supplementation from 6 months at 18 months of age

Arm/Group Title	No Food	Plumpy Doz	Wheat Soy Blend (WSB++)	Chickpea Based Complementary Food Supplement	Rice Based Complementary Food Supplement
Arm/Group Description:	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	1265	1344	770	769	755
Measure Type: Count of Participants; Unit of Measure: Participants
	559 44.2%	542 40.3%	341 44.3%	300 39.0%	330 43.7%

2. Secondary Outcome

Title	Morbidity
Description	weekly morbidity will be assessed for a year and episodes of diarrhea, dysentery ALRI, and fever will be recorded.
Time Frame	weekly from 6 to 18 months of age

Outcome Measure Data Not Reported

3. Secondary Outcome

Title	Body Composition
Description	Bioelectrical impedance analysis will be used to look at body composition changes from baseline until 18 months of age
Time Frame	At 6, 9 and 12 months of age

Outcome Measure Data Not Reported

4. Secondary Outcome

Title	Developmental Milestones
Description	Age-specific developmental milestones will be assessed
Time Frame	At 6, 12, and 18 months of age

Outcome Measure Data Not Reported

5. Secondary Outcome

Title	Cognitive and Motor Function
Description	Using Bayley III
Time Frame	At 18 months of age

Outcome Measure Data Not Reported

6. Secondary Outcome

Title	Micronutrient Status
Description	Iron, vitamin A, zinc and other micronutrient status of children will be examined by intervention group.
Time Frame	18 months of age

Outcome Measure Data Not Reported

7. Secondary Outcome

Title	Intestinal Function
Description	Intestinal function using L:M and other biomarkers will be assessed by intervention group and its association with child growth
Time Frame	At 24 months of age

Outcome Measure Data Not Reported

8. Other Pre-specified Outcome

Title	Maternal Knowledge, Attitude and Practice Related to Infant and Young Child Feeding
Description	Maternal KAP
Time Frame	At 6, 12 and 18 months of age

Outcome Measure Data Not Reported

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	No Food	Plumpy Doz	Wheat Soy Blend (WSB++)	Chickpea Based Complementary Food Supplement	Rice Based Complementary Food Supplement
Arm/Group Description	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.	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.	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.	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.	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.
All-Cause Mortality
	No Food	Plumpy Doz	Wheat Soy Blend (WSB++)	Chickpea Based Complementary Food Supplement	Rice Based Complementary Food Supplement
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	12/1438 (0.83%)	9/1492 (0.60%)	8/851 (0.94%)	6/843 (0.71%)	2/825 (0.24%)
Serious Adverse Events
	No Food	Plumpy Doz	Wheat Soy Blend (WSB++)	Chickpea Based Complementary Food Supplement	Rice Based Complementary Food Supplement
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/1438 (0.00%)	0/1492 (0.00%)	0/864 (0.00%)	0/860 (0.00%)	0/838 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	No Food	Plumpy Doz	Wheat Soy Blend (WSB++)	Chickpea Based Complementary Food Supplement	Rice Based Complementary Food Supplement
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/1438 (0.00%)	0/1492 (0.00%)	0/851 (0.00%)	0/843 (0.00%)	0/825 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Parul Christian
• Organization: Johns Hopkins Bloomberg School of Public Health
• Phone: 1-410-955-1188
• EMail: pchrist1@jhu.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Parul Christian, Johns Hopkins Bloomberg School of Public Health
• ClinicalTrials.gov Identifier: NCT01562379
• Other Study ID Numbers: 00003703; NIFA210-38418-21732 ( Other Grant/Funding Number: USDA )
• First Submitted: March 9, 2012
• First Posted: March 23, 2012
• Results First Submitted: December 3, 2017
• Results First Posted: August 24, 2018
• Last Update Posted: August 24, 2018