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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1957 participants

Primary outcome timeframe

12 weeks

Results posted on

2020-03-26

Participant Flow

Participant milestones

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

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 weeks

Population: 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

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 weeks

Subjects 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

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 weeks

Subjects 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

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 months

Any changes in recovery will be measured 6 months at follow-up visit. Number of children still well nourished.

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 42 deaths

Current Protocol

Serious events: 0 serious events
Other events: 0 other events
Deaths: 35 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

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place