Complementary Food Supplements for Reducing Childhood Undernutrition

• Sponsor: Johns Hopkins Bloomberg School of Public Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT01562379
• Collaborator: International Centre for Diarrhoeal Disease Research, Bangladesh (Other), United Nations World Food Programme (WFP) (Other), DSM Ltd (Industry)
• Enrollment: 5,449
• Location: 1
• Arms: 5
• Duration (Months): 26
• Patients Per Site Per Month: 209.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stunting; Wasting	Dietary Supplement: Wheat Soy Blend (WSB++); Dietary Supplement: Chickpea based complementary food supplement; Dietary Supplement: Rice based complementary food supplement; Dietary Supplement: Plumpy Doz	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 5449 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Evaluation of Complementary Food Supplements For Reducing Childhood Undernutrition: The JiVitA-4 Study
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.	Dietary Supplement: Plumpy Doz; Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals.
Experimental: Wheat Soy Blend (WSB++) Children will receive a WFP-developed Wheat-Soy Blend (WSB++) snack to be consumed daily.	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.
Experimental: Chickpea based complementary food supplement Children will receive a Chickpea based complementary food supplement to be consumed daily.	Dietary Supplement: Chickpea based complementary food supplement; A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals.
Experimental: Rice based complementary food supplement Children will receive a locally developed rice based complementary food supplement.	Dietary Supplement: Rice based complementary food supplement; Locally developed rice based complementary food with and added vitamins and minerals.

Outcome Measures

Primary Outcome Measures

1. Stunting in Children at 18 mo [18 months of age]

   Prevalence of stunting at 18 months of age.

Secondary Outcome Measures

1. Morbidity [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.

2. Body Composition [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

3. Developmental Milestones [At 6, 12, and 18 months of age]

   Age-specific developmental milestones will be assessed

4. Cognitive and Motor Function [At 18 months of age]

   Using Bayley III

5. Micronutrient Status [18 months of age]

   Iron, vitamin A, zinc and other micronutrient status of children will be examined by intervention group.

6. Intestinal Function [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

Other Outcome Measures

1. Maternal Knowledge, Attitude and Practice Related to Infant and Young Child Feeding [At 6, 12 and 18 months of age]

   Maternal KAP

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 8 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Infants 6 months of age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The JiVitA Project, Johns Hopkins Bangladesh	Gaibandha		Bangladesh

Sponsors and Collaborators

• Johns Hopkins Bloomberg School of Public Health
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Parul Christian, Professor, Johns Hopkins Bloomberg School of Public Health
• ClinicalTrials.gov Identifier: NCT01562379
• Other Study ID Numbers: 00003703; NIFA210-38418-21732
• First Posted: Mar 23, 2012
• Last Update Posted: Aug 24, 2018
• Last Verified: Dec 1, 2017

• Keywords provided by Parul Christian, Professor, Johns Hopkins Bloomberg School of Public Health: complementary food supplements; stunting; wasting; growth; Bangladesh; infant feeding
• Additional relevant MeSH terms: Wasting Syndrome; Malnutrition; Cachexia; Growth Disorders

Study Results

Participant Flow

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 Participants	1438	1492	851	843	825	5449
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	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 (Count of 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 (participants) [Number]
Bangladesh	1438 100%	1492 100%	851 100%	843 100%	852 103.3%	5476 100.5%

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.
Measure Participants	1265	1344	770	769	755
Count of Participants [Participants]	559 38.9%	542 36.3%	341 40.1%	300 35.6%	330 40%

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

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

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

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

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

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

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

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

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

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

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

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/1438 (0.8%)		9/1492 (0.6%)		8/851 (0.9%)		6/843 (0.7%)		2/825 (0.2%)
Serious Adverse Events
	No Food		Plumpy Doz		Wheat Soy Blend (WSB++)		Chickpea Based Complementary Food Supplement		Rice Based Complementary Food Supplement
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1438 (0%)		0/1492 (0%)		0/864 (0%)		0/860 (0%)		0/838 (0%)
Other (Not Including Serious) Adverse Events
	No Food		Plumpy Doz		Wheat Soy Blend (WSB++)		Chickpea Based Complementary Food Supplement		Rice Based Complementary Food Supplement
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1438 (0%)		0/1492 (0%)		0/851 (0%)		0/843 (0%)		0/825 (0%)

Limitations/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.