Moderate Acute Malnutrition (MAM) and Severe Acute Malnutrition (SAM) in Sierra Leone

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01785680
First received: January 29, 2013
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Malnutrition
Other: Integrated Protocol
Other: Current protocol

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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.


Estimated Enrollment: 1800
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)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with MAM or non-complicated SAM aged 6-59 months.
  • Have an acceptable appetite.judged by giving the child 30 g of RUTF and asking the mother to feed this food to the child over 20 minutes. Children with SAM who are able to consume this RUTF will be eligible for the study. Children unable to consume the RUTF or presenting with IMCI warning signs (convulsions, altered mental status, respiratory distress) will be considered to have complicated SAM and will be referred for inpatient treatment.
  • Only the youngest child with malnutrition in each household will be enrolled; older siblings with MAM or SAM will be treated operationally using the same protocol.

Exclusion Criteria:

  • Children with obvious chronic debilitating illness like cerebral palsy or congenital abnormalities
  • Children having received treatment for MAM or SAM in the previous two months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785680

Contacts
Contact: Mark Manary, MD 314 454-2178 manary@kids.wustl.edu
Contact: Ellen Murray, BA 314-747-2771 murray_e@kids.wustl.edu

Locations
Sierra Leone
Project Peanut Butter Factory - 41D Wilkinson Road Recruiting
Freetown, Sierra Leone
Contact: Amanda Maust, RN, MSW       amandamaust@gmail.com   
Contact: Stephanie Peace       live4f8th@gmail.com   
Principal Investigator: Mark Manary, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Mark Manary, MD Washington University Early Recognition Center
  More Information

Additional Information:
Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01785680     History of Changes
Other Study ID Numbers: 201211096, U01GH000647-01
Study First Received: January 29, 2013
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
MAM
SAM

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on July 31, 2014