Trial Outcomes & Findings for Complementary Food Supplements for Reducing Childhood Undernutrition (NCT NCT01562379)

Results Overview

Prevalence of stunting at 18 months of age.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

5449 participants

Primary outcome timeframe

18 months of age

Results posted on

2018-08-24

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.
Overall Study STARTED	1438	1492	851	843	825
Overall Study COMPLETED	1312	1395	789	786	785
Overall Study NOT COMPLETED	126	97	62	57	40

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Complementary Food Supplements for Reducing Childhood Undernutrition

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Food n=1438 Participants 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.	Plumpy Doz n=1492 Participants 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.	Wheat Soy Blend (WSB++) n=851 Participants 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.	Chickpea Based Complementary Food Supplement n=843 Participants 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.	Rice Based Complementary Food Supplement n=825 Participants 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 n=5449 Participants Total of all reporting groups
Age, Continuous	6.13 months STANDARD_DEVIATION 0.0 • n=5 Participants	6.26 months STANDARD_DEVIATION 0.26 • n=7 Participants	6.26 months STANDARD_DEVIATION 0.27 • n=5 Participants	6.24 months STANDARD_DEVIATION 0.25 • n=4 Participants	6.25 months STANDARD_DEVIATION 0.25 • n=21 Participants	6.23 months STANDARD_DEVIATION 0.21 • n=10 Participants
Sex: Female, Male Female	752 Participants n=5 Participants	725 Participants n=7 Participants	432 Participants n=5 Participants	424 Participants n=4 Participants	425 Participants n=21 Participants	2758 Participants n=10 Participants
Sex: Female, Male Male	686 Participants n=5 Participants	767 Participants n=7 Participants	419 Participants n=5 Participants	419 Participants n=4 Participants	400 Participants n=21 Participants	2691 Participants n=10 Participants
Region of Enrollment Bangladesh	1438 participants n=5 Participants	1492 participants n=7 Participants	851 participants n=5 Participants	843 participants n=4 Participants	852 participants n=21 Participants	5476 participants n=10 Participants

PRIMARY outcome

Timeframe: 18 months of age

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

Prevalence of stunting at 18 months of age.

Outcome measures

Outcome measures
Measure	No Food n=1265 Participants 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.	Plumpy Doz n=1344 Participants 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.	Wheat Soy Blend (WSB++) n=770 Participants 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.	Chickpea Based Complementary Food Supplement n=769 Participants 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.	Rice Based Complementary Food Supplement n=755 Participants 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.
Stunting in Children at 18 mo	559 Participants	542 Participants	341 Participants	300 Participants	330 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Age-specific developmental milestones will be assessed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 18 months of age

Using Bayley III

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months of age

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At 6, 12 and 18 months of age

Maternal KAP