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Complementary Food Supplements for Reducing Childhood Undernutrition

Evaluation of Complementary Food Supplements For Reducing Childhood Undernutrition: The JiVitA-4 Study

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01562379
Enrollment
5449
Registered
2012-03-23
Start date
2012-09-30
Completion date
2014-11-30
Last updated
2018-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stunting, Wasting

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTWheat 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.

DIETARY_SUPPLEMENTChickpea based complementary food supplement

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

DIETARY_SUPPLEMENTRice based complementary food supplement

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

DIETARY_SUPPLEMENTPlumpy Doz

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

Sponsors

International Centre for Diarrhoeal Disease Research, Bangladesh
CollaboratorOTHER
United Nations World Food Programme (WFP)
CollaboratorOTHER
DSM Ltd
CollaboratorINDUSTRY
Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 8 Months
Healthy volunteers
Yes

Inclusion criteria

* Infants 6 months of age

Design outcomes

Primary

MeasureTime frameDescription
Stunting in Children at 18 mo18 months of agePrevalence of stunting at 18 months of age.

Secondary

MeasureTime frameDescription
Morbidityweekly from 6 to 18 months of ageweekly morbidity will be assessed for a year and episodes of diarrhea, dysentery ALRI, and fever will be recorded.
Body CompositionAt 6, 9 and 12 months of ageBioelectrical impedance analysis will be used to look at body composition changes from baseline until 18 months of age
Developmental MilestonesAt 6, 12, and 18 months of ageAge-specific developmental milestones will be assessed
Micronutrient Status18 months of ageIron, vitamin A, zinc and other micronutrient status of children will be examined by intervention group.
Intestinal FunctionAt 24 months of ageIntestinal function using L:M and other biomarkers will be assessed by intervention group and its association with child growth
Cognitive and Motor FunctionAt 18 months of ageUsing Bayley III

Other

MeasureTime frameDescription
Maternal Knowledge, Attitude and Practice Related to Infant and Young Child FeedingAt 6, 12 and 18 months of ageMaternal KAP

Countries

Bangladesh

Participant flow

Participants by arm

ArmCount
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.
1,438
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.
1,492
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.
851
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.
843
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.
825
Total5,449

Baseline characteristics

CharacteristicNo FoodPlumpy DozWheat Soy Blend (WSB++)Chickpea Based Complementary Food SupplementRice Based Complementary Food SupplementTotal
Age, Continuous6.13 months
STANDARD_DEVIATION 0
6.26 months
STANDARD_DEVIATION 0.26
6.26 months
STANDARD_DEVIATION 0.27
6.24 months
STANDARD_DEVIATION 0.25
6.25 months
STANDARD_DEVIATION 0.25
6.23 months
STANDARD_DEVIATION 0.21
Region of Enrollment
Bangladesh
1438 participants1492 participants851 participants843 participants852 participants5476 participants
Sex: Female, Male
Female
752 Participants725 Participants432 Participants424 Participants425 Participants2758 Participants
Sex: Female, Male
Male
686 Participants767 Participants419 Participants419 Participants400 Participants2691 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
12 / 1,4389 / 1,4928 / 8516 / 8432 / 825
other
Total, other adverse events
0 / 1,4380 / 1,4920 / 8510 / 8430 / 825
serious
Total, serious adverse events
0 / 1,4380 / 1,4920 / 8640 / 8600 / 838

Outcome results

Primary

Stunting in Children at 18 mo

Prevalence of stunting at 18 months of age.

Time frame: 18 months of age

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
No FoodStunting in Children at 18 mo559 Participants
Plumpy DozStunting in Children at 18 mo542 Participants
Wheat Soy Blend (WSB++)Stunting in Children at 18 mo341 Participants
Chickpea Based Complementary Food SupplementStunting in Children at 18 mo300 Participants
Rice Based Complementary Food SupplementStunting in Children at 18 mo330 Participants
Secondary

Body Composition

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

Secondary

Cognitive and Motor Function

Using Bayley III

Time frame: At 18 months of age

Secondary

Developmental Milestones

Age-specific developmental milestones will be assessed

Time frame: At 6, 12, and 18 months of age

Secondary

Intestinal Function

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

Secondary

Micronutrient Status

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

Time frame: 18 months of age

Secondary

Morbidity

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

Other Pre-specified

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

Maternal KAP

Time frame: At 6, 12 and 18 months of age

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026