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StuntingPhase 2/3NCT01562379

Complementary Food Supplements for Reducing Childhood Undernutrition

A Phase 2/3 study testing Wheat Soy Blend (WSB++), Chickpea based complementary food supplement and Rice based complementary food supplement in people with Stunting and Wasting, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 8 monthsHealthy volunteers can take part
Conditions the study is for
Stunting, Wasting
What is being tested?
Wheat Soy Blend (WSB++), Chickpea based complementary food supplement and Rice based complementary food supplement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,449 participants
Where
1 siteBangladesh
Study dates
Sep 2012to Nov 2014
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 8 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Infants 6 months of age

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

  • The JiVitA Project, Johns Hopkins Bangladesh

    Gaibandha

Other trials in Bangladesh

About this study

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

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.

Read the 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.

Conditions
Stunting, Wasting
Being tested
Wheat Soy Blend (WSB++), Chickpea based complementary food supplement, Rice based complementary food supplement, Plumpy Doz
Keywords
complementary food supplements, stunting, wasting, growth, Bangladesh, infant feeding
Medical subject headings
Growth Disorders, Cachexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Chickpea based complementary food supplementDietary supplement

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

  • Rice based complementary food supplementDietary supplement

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

  • Plumpy DozDietary supplement

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

Study groups in NCT01562379
Study groupRoleWhat they receive
No foodNo interventionA 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 DozActive comparatorIn this control arm children will receive prepackaged, lipid-based Plumpy'Doz (Nutriset, Mulaunay, France) for daily consumption as a snack.
Receives: Dietary Supplement: Plumpy Doz
Wheat Soy Blend (WSB++)ExperimentalChildren will receive a WFP-developed Wheat-Soy Blend (WSB++) snack to be consumed daily.
Receives: Dietary Supplement: Wheat Soy Blend (WSB++)
Chickpea based complementary food supplementExperimentalChildren will receive a Chickpea based complementary food supplement to be consumed daily.
Receives: Dietary Supplement: Chickpea based complementary food supplement
Rice based complementary food supplementExperimentalChildren will receive a locally developed rice based complementary food supplement.
Receives: Dietary Supplement: Rice based complementary food supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stunting in Children at 18 mo

    Prevalence of stunting at 18 months of age.

    Measured: 18 months of age

Secondary outcomes (6)

  1. Morbidity

    weekly morbidity will be assessed for a year and episodes of diarrhea, dysentery ALRI, and fever will be recorded.

    Measured: weekly from 6 to 18 months of age

  2. Body Composition

    Bioelectrical impedance analysis will be used to look at body composition changes from baseline until 18 months of age

    Measured: At 6, 9 and 12 months of age

  3. Developmental Milestones

    Age-specific developmental milestones will be assessed

    Measured: At 6, 12, and 18 months of age

  4. Cognitive and Motor Function

    Using Bayley III

    Measured: At 18 months of age

  5. Micronutrient Status

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

    Measured: 18 months of age

  6. Intestinal Function

    Intestinal function using L:M and other biomarkers will be assessed by intervention group and its association with child growth

    Measured: At 24 months of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionMay 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5,449 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01562379
Sponsor's protocol ID
00003703
Other IDs
NIFA210-38418-21732
Status last verified
Dec 2017
First submitted
9 Mar 2012
Last updated
24 Aug 2018
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 39662676

  • 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.

    PubMed 32875267

  • 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.

    PubMed 32240304

  • 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.

    PubMed 30184222

  • 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.

    PubMed 28644348

  • 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.

    PubMed 27680994

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Wheat Soy Blend (WSB++), Chickpea based complementary food supplement and Rice based complementary food supplement in people with Stunting and Wasting, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stunting in Children at 18 mo (time frame: 18 months of age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01562379, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.

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