Moderate Acute Malnutrition (MAM) and Severe Acute Malnutrition (SAM) in Sierra Leone
Recruitment status was: Recruiting
The long-term objective of this proposal is to develop and demonstrate an effective, integrated and streamlined protocol to treat moderate acute malnutrition (MAM) and non-complicated severe acute malnutrition (SAM) in children during humanitarian emergencies.
Hypothesis: An integrated management protocol for MAM and SAM will achieve greater community coverage and a greater individual recovery rate than standard care.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Conducting Research on Moderate Acute Malnutrition in Humanitarian Emergencies Integrated Management of MAM and SAM in Sierra Leone With Ready to Use Theraputic Foods (RUTF)|
- Recovery under the integrated program and the standard protocol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Recovery at 1, 3 and 6 months follow-up with the 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. Follow-up recovery will then be measured at 1, 3, and 6 months.
- Change in Growth rates [ Time Frame: 12 weeks, 1, 3, 6 months ] [ Designated as safety issue: No ]Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed. Follow-up recovery will then be measured at 1, 3, and 6 months. At each clinic visit growth will be measured.
- Duration of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed. Follow-up recovery will then be measured at 1, 3, and 6 months. Time to achieve MUAC of 12.5 cm will be documented.
- Cost estimates for participation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Average cost of treatment will be measured per participant, this includes intervention costs and any medical costs needed by participants. The study costs no money to participants.
- Default reason [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]If a child defaults, then the reason will be an outcome measure. Reasons to default include loss to follow-up (the child will be attempted to be contacted 3 times prior to being considered lost), death, or he/she enters into the inpatient clinic.
- Change in recovery status after 12 weeks [ Time Frame: 6 months ] [ Designated as safety issue: No ]Any changes in recovery will be measured at 1, 3, and 6 months at follow-up visits
- Coverage [ Time Frame: 1 month ] [ Designated as safety issue: No ]Evaluation of Access and Coverage (SLEAQ Coverage) will be measured in the communities in Sierra Leone. This is a survey analysis of the coverage our treatment has in the regions we are serving in Sierra Leone. This will measure the effectiveness we have in treating malnutrition in the region not just within our patient population.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Active Comparator: 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.
Other: 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.
Experimental: 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.
Other: 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 months. Caretakers will be instructed to seek medical care sooner if the child has fever, poor appetite or signs of an acute illness.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01785680
|Project Peanut Butter Factory - 41D Wilkinson Road|
|Freetown, Sierra Leone|
|Principal Investigator:||Mark Manary, MD||Washington University School of Medicine|