Trial Outcomes & Findings for The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 6-11 Months (NCT NCT02472262)
NCT ID: NCT02472262
Last Updated: 2019-12-02
Results Overview
Change in length-for-age z score from enrollment to end of study 6 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
355 participants
Primary outcome timeframe
6 months
Results posted on
2019-12-02
Participant Flow
Participant milestones
| Measure |
Cow Pea Complementary Food
A legume-based complementary food made from cowpeas will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
Cow pea complementary food: A legume-based complementary food made from cowpeas will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
|
Common Bean
A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
Common bean: A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
|
Corn Soy Flour
Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
Corn soy flour: Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
|
|---|---|---|---|
|
Overall Study
STARTED
|
117
|
120
|
118
|
|
Overall Study
COMPLETED
|
99
|
99
|
93
|
|
Overall Study
NOT COMPLETED
|
18
|
21
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 6-11 Months
Baseline characteristics by cohort
| Measure |
Cow Pea Complementary Food
n=117 Participants
A legume-based complementary food made from cowpeas will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
Cow pea complementary food: A legume-based complementary food made from cowpeas will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
|
Common Bean
n=120 Participants
A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
Common bean: A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
|
Corn Soy Flour
n=118 Participants
Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
Corn soy flour: Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
|
Total
n=355 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
117 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
355 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
5.8 months
STANDARD_DEVIATION 0.3 • n=5 Participants
|
5.8 months
STANDARD_DEVIATION 0.3 • n=7 Participants
|
5.8 months
STANDARD_DEVIATION 0.4 • n=5 Participants
|
5.8 months
STANDARD_DEVIATION 0.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
172 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
183 Participants
n=4 Participants
|
|
Region of Enrollment
Malawi
|
117 participants
n=5 Participants
|
120 participants
n=7 Participants
|
118 participants
n=5 Participants
|
355 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsChange in length-for-age z score from enrollment to end of study 6 months
Outcome measures
| Measure |
Cow Pea Complementary Food
n=99 Participants
A legume-based complementary food made from cowpeas will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
Cow pea complementary food: A legume-based complementary food made from cowpeas will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
|
Common Bean
n=99 Participants
A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
Common bean: A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
|
Corn Soy Flour
n=93 Participants
Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
Corn soy flour: Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
|
|---|---|---|---|
|
Change in Length-for-age z Score Over 6 Months From Enrollment to End of Study.
|
-0.14 z-score
Interval -0.24 to -0.04
|
-0.27 z-score
Interval -0.38 to -0.16
|
-0.27 z-score
Interval -0.35 to -0.19
|
PRIMARY outcome
Timeframe: 6 monthpercent of lactulose found in urine during the dual sugar absorption test
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsMid-upper arm circumference in cm
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsweight for height z-score at 9 and 12 months of age
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
Adverse Events
Cow Pea Complementary Food
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Common Bean
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Corn Soy Flour
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mark Manary
Washington University School of Medicine in St. Louis
Phone: 3144542178
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place