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

NCT01785680 | Completed Results DMC

• 2 other identifiers: 201211096U01GH000647-01
• Study Type: interventional
• Target: 1,957
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malnutrition

Keywords

MAM; SAM

Outcome Measures

Primary Outcomes (1)

• Recovery Under the Integrated Program and the Standard Protocol

  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.

  12 weeks

Secondary Outcomes (3)

• Change in Growth Rates

  12 weeks

• Duration of Treatment

  12 weeks

• Change in Recovery Status After 12 Weeks

  6 months

Study Arms (2)

Current protocol

ACTIVE COMPARATOR

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

Integrated Protocol

EXPERIMENTAL

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

Interventions

Integrated Protocol OTHER

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.

Integrated Protocol

Current protocol OTHER

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.

Current protocol

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Project Peanut Butter Factory - 41D Wilkinson Road

Freetown, Sierra Leone

Location

Related Publications (7)

• Myatt M, Khara T, Collins S. A review of methods to detect cases of severely malnourished children in the community for their admission into community-based therapeutic care programs. Food Nutr Bull. 2006 Sep;27(3 Suppl):S7-23. doi: 10.1177/15648265060273S302.

  PMID: 17076211 BACKGROUND

• Islam MM, Khatun M, Peerson JM, Ahmed T, Mollah MA, Dewey KG, Brown KH. Effects of energy density and feeding frequency of complementary foods on total daily energy intakes and consumption of breast milk by healthy breastfed Bangladeshi children. Am J Clin Nutr. 2008 Jul;88(1):84-94. doi: 10.1093/ajcn/88.1.84.

  PMID: 18614728 BACKGROUND

• Nackers F, Broillet F, Oumarou D, Djibo A, Gaboulaud V, Guerin PJ, Rusch B, Grais RF, Captier V. Effectiveness of ready-to-use therapeutic food compared to a corn/soy-blend-based pre-mix for the treatment of childhood moderate acute malnutrition in Niger. J Trop Pediatr. 2010 Dec;56(6):407-13. doi: 10.1093/tropej/fmq019. Epub 2010 Mar 23.

  PMID: 20332221 BACKGROUND

• LaGrone LN, Trehan I, Meuli GJ, Wang RJ, Thakwalakwa C, Maleta K, Manary MJ. A novel fortified blended flour, corn-soy blend "plus-plus," is not inferior to lipid-based ready-to-use supplementary foods for the treatment of moderate acute malnutrition in Malawian children. Am J Clin Nutr. 2012 Jan;95(1):212-9. doi: 10.3945/ajcn.111.022525. Epub 2011 Dec 14.

  PMID: 22170366 BACKGROUND

• Oakley E, Reinking J, Sandige H, Trehan I, Kennedy G, Maleta K, Manary M. A ready-to-use therapeutic food containing 10% milk is less effective than one with 25% milk in the treatment of severely malnourished children. J Nutr. 2010 Dec;140(12):2248-52. doi: 10.3945/jn.110.123828. Epub 2010 Oct 27.

  PMID: 20980648 BACKGROUND

• Galpin L, Thakwalakwa C, Phuka J, Ashorn P, Maleta K, Wong WW, Manary MJ. Breast milk intake is not reduced more by the introduction of energy dense complementary food than by typical infant porridge. J Nutr. 2007 Jul;137(7):1828-33. doi: 10.1093/jn/137.7.1828.

  PMID: 17585038 BACKGROUND

• Maust A, Koroma AS, Abla C, Molokwu N, Ryan KN, Singh L, Manary MJ. Severe and Moderate Acute Malnutrition Can Be Successfully Managed with an Integrated Protocol in Sierra Leone. J Nutr. 2015 Nov;145(11):2604-9. doi: 10.3945/jn.115.214957. Epub 2015 Sep 30.

  PMID: 26423737 RESULT

Related Links

• WHO Multicentre Growth Reference Study Group. WHO Child Growth Standards: Length/ height-for-age, weight-for-age, weight-for-length, weight-for-height and body mass index-for-age: Methods and development. Geneva; 2006
• Measuring the effectiveness of Supplementary Feeding Programmes in emergencies. Humanitarian Practice Network. 2008
• World Relief. The Care Group Difference
• Anon. The U.S. President's Emergency Plan for AIDS Relief
• World Health Organization and UNICEF. Integrated Management of Childhood Illness (IMCI) Handbook. Geneva; 2005

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Mark Manary
• Organization: Washington University School of Medicine in St. Louis

manary@kids.wustl.edu

3144542178

Study Officials

• Mark Manary, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: February 7, 2013
• Study Start: January 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 26, 2020
• Results First Posted: March 26, 2020

Record last verified: 2020-03

Locations

SI (1)