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Complementary Food Supplements for Reducing Childhood Undernutrition

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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:
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
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
Hide 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
Arm/Group Title No Food Plumpy Doz Wheat Soy Blend (WSB++) Chickpea Based Complementary Food Supplement Rice Based Complementary Food Supplement Total
Hide 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
Hide 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
1.Primary Outcome
Title Stunting in Children at 18 mo
Hide Description Prevalence of stunting at 18 months of age.
Time Frame 18 months of age
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide Description Using Bayley III
Time Frame At 18 months of age
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Micronutrient Status
Hide 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
Hide 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
Hide Description Maternal KAP
Time Frame At 6, 12 and 18 months of age
Outcome Measure Data Not Reported
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
Hide 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%) 
Hide 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%) 
Hide 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%) 
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
Layout table for Results Point of Contact information
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):
Layout table for additonal information
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