Trial Outcomes & Findings for Moderate Acute Malnutrition (MAM) and Severe Acute Malnutrition (SAM) in Sierra Leone (NCT NCT01785680)
NCT ID: NCT01785680
Last Updated: 2020-03-26
Results Overview
Recovery by the end of treatment standard protocol will be compared to the integrated protocol. Recovery will be defined as mid upper arm circumference (MUAC) reaching ≥12.5 cm. Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed.
COMPLETED
NA
1957 participants
12 weeks
2020-03-26
Participant Flow
Participant milestones
| Measure |
Integrated Protocol
Integrated protocol for treatment of children with MAM and SAM in humanitarian emergencies has the potential to result in a more streamlined, cost-effective program, higher recovery, and higher program coverage, allowing easier access to malnourished children, thus curing more children of malnutrition and preventing its lifelong effects.
Integrated Protocol: Implement an integrated protocol in Sierra Leone for the management of MAM and non-complicated SAM that uses a single anthropometric indicator as well as the same food but in different doses to treat the continuum of malnutrition. MAM children will be given 75 g/kg/day of RUTF whereas SAM will be given 175 gr/kg/day of RUTF until MUAC\>12.5 cm is reached. Then child will be given LNS, a bed net, albendazole, zinc, referral for immunizations compliant with current WHO recommendations, oral rehydration salts to give if the child has more than three loose watery stools in 24 hours, and asked to return for follow-up in 1, 3 and 6 m
|
Current Protocol
These treatment arm is the standard care for moderate malnutrition. This includes a fortified cereal supplement treatment until the child reaches MUAC of above 12.5. Currently, MAM and SAM are treated separately, overseen by different agencies. Breastfeeding is often overlooked.
Current protocol: Current protocol for treating MAM in emergencies is supplemental food distribution, often providing a fortified blended food (FBF) that requires cooking. This treatment is the standard today for treating children with MAM.
|
|---|---|---|
|
Overall Study
STARTED
|
1100
|
857
|
|
Overall Study
COMPLETED
|
1100
|
857
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Moderate Acute Malnutrition (MAM) and Severe Acute Malnutrition (SAM) in Sierra Leone
Baseline characteristics by cohort
| Measure |
Integrated Protocol
n=1100 Participants
Integrated protocol for treatment of children with MAM and SAM in humanitarian emergencies has the potential to result in a more streamlined, cost-effective program, higher recovery, and higher program coverage, allowing easier access to malnourished children, thus curing more children of malnutrition and preventing its lifelong effects.
Integrated Protocol: Implement an integrated protocol in Sierra Leone for the management of MAM and non-complicated SAM that uses a single anthropometric indicator as well as the same food but in different doses to treat the continuum of malnutrition. MAM children will be given 75 g/kg/day of RUTF whereas SAM will be given 175 gr/kg/day of RUTF until MUAC\>12.5 cm is reached. Then child will be given LNS, a bed net, albendazole, zinc, referral for immunizations compliant with current WHO recommendations, oral rehydration salts to give if the child has more than three loose watery stools in 24 hours, and asked to return for follow-up in 1, 3 and 6 m
|
Current Protocol
n=857 Participants
These treatment arm is the standard care for moderate malnutrition. This includes a fortified cereal supplement treatment until the child reaches MUAC of above 12.5. Currently, MAM and SAM are treated separately, overseen by different agencies. Breastfeeding is often overlooked.
Current protocol: Current protocol for treating MAM in emergencies is supplemental food distribution, often providing a fortified blended food (FBF) that requires cooking. This treatment is the standard today for treating children with MAM.
|
Total
n=1957 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.7 months
STANDARD_DEVIATION 8.6 • n=99 Participants
|
14.5 months
STANDARD_DEVIATION 7.8 • n=107 Participants
|
14.1 months
STANDARD_DEVIATION 8.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
619 Participants
n=99 Participants
|
478 Participants
n=107 Participants
|
1097 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
481 Participants
n=99 Participants
|
379 Participants
n=107 Participants
|
860 Participants
n=206 Participants
|
|
Region of Enrollment
Sierra Leone
|
1100 participants
n=99 Participants
|
857 participants
n=107 Participants
|
1957 participants
n=206 Participants
|
|
Midupper arm circumference
|
12.1 cm
STANDARD_DEVIATION 0.3 • n=99 Participants
|
11.4 cm
STANDARD_DEVIATION 1.0 • n=107 Participants
|
11.8 cm
STANDARD_DEVIATION 0.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Recovery was defined as mid upper arm circumference ≥12.5 cm.
Recovery by the end of treatment standard protocol will be compared to the integrated protocol. Recovery will be defined as mid upper arm circumference (MUAC) reaching ≥12.5 cm. Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed.
Outcome measures
| Measure |
Integrated Protocol
n=1100 Participants
Integrated protocol for treatment of children with MAM and SAM in humanitarian emergencies has the potential to result in a more streamlined, cost-effective program, higher recovery, and higher program coverage, allowing easier access to malnourished children, thus curing more children of malnutrition and preventing its lifelong effects.
Integrated Protocol: Implement an integrated protocol in Sierra Leone for the management of MAM and non-complicated SAM that uses a single anthropometric indicator as well as the same food but in different doses to treat the continuum of malnutrition. MAM children will be given 75 g/kg/day of RUTF whereas SAM will be given 175 gr/kg/day of RUTF until MUAC\>12.5 cm is reached. Then child will be given LNS, a bed net, albendazole, zinc, referral for immunizations compliant with current WHO recommendations, oral rehydration salts to give if the child has more than three loose watery stools in 24 hours, and asked to return for follow-up in 1, 3 and 6 m
|
Current Protocol
n=857 Participants
These treatment arm is the standard care for moderate malnutrition. This includes a fortified cereal supplement treatment until the child reaches MUAC of above 12.5. Currently, MAM and SAM are treated separately, overseen by different agencies. Breastfeeding is often overlooked.
Current protocol: Current protocol for treating MAM in emergencies is supplemental food distribution, often providing a fortified blended food (FBF) that requires cooking. This treatment is the standard today for treating children with MAM.
|
|---|---|---|
|
Recovery Under the Integrated Program and the Standard Protocol
|
910 Participants
|
682 Participants
|
SECONDARY outcome
Timeframe: 12 weeksSubjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed. Measurement is taken at each visit but final recovery measurement will be used.
Outcome measures
| Measure |
Integrated Protocol
n=1100 Participants
Integrated protocol for treatment of children with MAM and SAM in humanitarian emergencies has the potential to result in a more streamlined, cost-effective program, higher recovery, and higher program coverage, allowing easier access to malnourished children, thus curing more children of malnutrition and preventing its lifelong effects.
Integrated Protocol: Implement an integrated protocol in Sierra Leone for the management of MAM and non-complicated SAM that uses a single anthropometric indicator as well as the same food but in different doses to treat the continuum of malnutrition. MAM children will be given 75 g/kg/day of RUTF whereas SAM will be given 175 gr/kg/day of RUTF until MUAC\>12.5 cm is reached. Then child will be given LNS, a bed net, albendazole, zinc, referral for immunizations compliant with current WHO recommendations, oral rehydration salts to give if the child has more than three loose watery stools in 24 hours, and asked to return for follow-up in 1, 3 and 6 m
|
Current Protocol
n=857 Participants
These treatment arm is the standard care for moderate malnutrition. This includes a fortified cereal supplement treatment until the child reaches MUAC of above 12.5. Currently, MAM and SAM are treated separately, overseen by different agencies. Breastfeeding is often overlooked.
Current protocol: Current protocol for treating MAM in emergencies is supplemental food distribution, often providing a fortified blended food (FBF) that requires cooking. This treatment is the standard today for treating children with MAM.
|
|---|---|---|
|
Change in Growth Rates
|
0.52 cm
Standard Deviation 0.04
|
0.25 cm
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: 12 weeksSubjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed. Time to achieve MUAC of 12.5 cm will be documented.
Outcome measures
| Measure |
Integrated Protocol
n=1100 Participants
Integrated protocol for treatment of children with MAM and SAM in humanitarian emergencies has the potential to result in a more streamlined, cost-effective program, higher recovery, and higher program coverage, allowing easier access to malnourished children, thus curing more children of malnutrition and preventing its lifelong effects.
Integrated Protocol: Implement an integrated protocol in Sierra Leone for the management of MAM and non-complicated SAM that uses a single anthropometric indicator as well as the same food but in different doses to treat the continuum of malnutrition. MAM children will be given 75 g/kg/day of RUTF whereas SAM will be given 175 gr/kg/day of RUTF until MUAC\>12.5 cm is reached. Then child will be given LNS, a bed net, albendazole, zinc, referral for immunizations compliant with current WHO recommendations, oral rehydration salts to give if the child has more than three loose watery stools in 24 hours, and asked to return for follow-up in 1, 3 and 6 m
|
Current Protocol
n=857 Participants
These treatment arm is the standard care for moderate malnutrition. This includes a fortified cereal supplement treatment until the child reaches MUAC of above 12.5. Currently, MAM and SAM are treated separately, overseen by different agencies. Breastfeeding is often overlooked.
Current protocol: Current protocol for treating MAM in emergencies is supplemental food distribution, often providing a fortified blended food (FBF) that requires cooking. This treatment is the standard today for treating children with MAM.
|
|---|---|---|
|
Duration of Treatment
|
2.7 Number of clinic visits
Standard Deviation 0.06
|
3.5 Number of clinic visits
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: 6 monthsAny changes in recovery will be measured 6 months at follow-up visit. Number of children still well nourished.
Outcome measures
| Measure |
Integrated Protocol
n=604 Participants
Integrated protocol for treatment of children with MAM and SAM in humanitarian emergencies has the potential to result in a more streamlined, cost-effective program, higher recovery, and higher program coverage, allowing easier access to malnourished children, thus curing more children of malnutrition and preventing its lifelong effects.
Integrated Protocol: Implement an integrated protocol in Sierra Leone for the management of MAM and non-complicated SAM that uses a single anthropometric indicator as well as the same food but in different doses to treat the continuum of malnutrition. MAM children will be given 75 g/kg/day of RUTF whereas SAM will be given 175 gr/kg/day of RUTF until MUAC\>12.5 cm is reached. Then child will be given LNS, a bed net, albendazole, zinc, referral for immunizations compliant with current WHO recommendations, oral rehydration salts to give if the child has more than three loose watery stools in 24 hours, and asked to return for follow-up in 1, 3 and 6 m
|
Current Protocol
n=474 Participants
These treatment arm is the standard care for moderate malnutrition. This includes a fortified cereal supplement treatment until the child reaches MUAC of above 12.5. Currently, MAM and SAM are treated separately, overseen by different agencies. Breastfeeding is often overlooked.
Current protocol: Current protocol for treating MAM in emergencies is supplemental food distribution, often providing a fortified blended food (FBF) that requires cooking. This treatment is the standard today for treating children with MAM.
|
|---|---|---|
|
Change in Recovery Status After 12 Weeks
|
544 Participants
|
459 Participants
|
Adverse Events
Integrated Protocol
Current Protocol
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place