NCT03647150

Brief Summary

This project explores whether children have better growth and cognitive development when the clinic identifies "higher risk" MAM children and support them either with the same treatment as SAM children or with the recommended practice: nutrition counseling.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,322

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

November 13, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2020

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

1.6 years

First QC Date

July 31, 2018

Last Update Submit

August 29, 2020

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

  • Recovery from moderate acute malnutrition (MAM)

    proportion of participants recovered based on mid-upper arm circumference(MUAC) Recovery is defined as MUAC greater than or equal to 12.5cm before or at 12 weeks after enrollment.

    up to 12 weeks of treatment

Secondary Outcomes (6)

  • Participant survival rates

    Duration of the study 24 weeks post-enrollment

  • Participants deterioration to severe acute malnutrition(SAM)

    Duration of the study 24 weeks post-enrollment

  • Participants that remain or become underweight using weight for age z-score

    24 weeks post-enrollment

  • Participants that remain or become Stunted

    24 weeks post-enrollment

  • Participants that remain or become Wasted

    24 weeks post-enrollment

  • +1 more secondary outcomes

Study Arms (2)

Moderate Acute Malnutrition (MAM)

OTHER

MAM children at control clinics or MAM children at intervention clinics that do no have high rick characteristics. Control treatment is "Mother Care" counselling, delivered by a respected elder in the local community.

Behavioral: Mother Care group

High Risk Moderate Acute Malnutrition (MAM)

EXPERIMENTAL

The intervention treatment incorporates Mother Care counselling, provision of one packet (508 calories) of ready-to-use therapeutic food (RUTF) daily and a 1 week course of amoxicillin. This provision will continue until the child has reached a mid-upper arm circumference (MUAC) equal to or greater than 12.5 cm or 12 weeks have elapsed.

Drug: amoxicillinDietary Supplement: Ready-to-use therapeutic food (RUTF)Behavioral: Mother Care group

Interventions

amoxicillinDRUG

At enrollment the child will receive a 1 week course of amoxicillin

High Risk Moderate Acute Malnutrition (MAM)
Ready-to-use therapeutic food (RUTF)DIETARY_SUPPLEMENT

1 sachet RUTF per day (508 calories) till child MUAC is greater than 12.4 cm or 12 weeks have elapsed

High Risk Moderate Acute Malnutrition (MAM)
Mother Care groupBEHAVIORAL

Nutrition education via mother care groups lead by a respected elder in the local community

High Risk Moderate Acute Malnutrition (MAM)Moderate Acute Malnutrition (MAM)

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • uncomplicated MAM (based on MUAC equal to or greater than 11.5 cm and \<12.5)

You may not qualify if:

  • currently involved in another research trial or feeding program
  • medical complication such as oedema, severe nausea/vomiting, severe dehydration, or severe pneumonia
  • have a diagnosed or visible sign of developmental delay
  • have a history of peanut or milk allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Project Peanut Butter

Freetown, Sierra Leone

Location

Related Publications (8)

  • Joshua GE, Jadhav M, Bhaktaviziam A, Mokashi S. Mental retardation in children. II. Leucodystrophies. Indian Pediatr. 1974 Jan;11(1):53-9. No abstract available.

    PMID: 4839581BACKGROUND

  • Lenters LM, Wazny K, Webb P, Ahmed T, Bhutta ZA. Treatment of severe and moderate acute malnutrition in low- and middle-income settings: a systematic review, meta-analysis and Delphi process. BMC Public Health. 2013;13 Suppl 3(Suppl 3):S23. doi: 10.1186/1471-2458-13-S3-S23. Epub 2013 Sep 17.

    PMID: 24564235BACKGROUND

  • Chang CY, Trehan I, Wang RJ, Thakwalakwa C, Maleta K, Deitchler M, Manary MJ. Children successfully treated for moderate acute malnutrition remain at risk for malnutrition and death in the subsequent year after recovery. J Nutr. 2013 Feb;143(2):215-20. doi: 10.3945/jn.112.168047. Epub 2012 Dec 19.

    PMID: 23256140BACKGROUND

  • 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: 26423737BACKGROUND

  • Ekelund U, Ong KK, Linne Y, Neovius M, Brage S, Dunger DB, Wareham NJ, Rossner S. Association of weight gain in infancy and early childhood with metabolic risk in young adults. J Clin Endocrinol Metab. 2007 Jan;92(1):98-103. doi: 10.1210/jc.2006-1071. Epub 2006 Oct 10.

    PMID: 17032722BACKGROUND

  • Khara T, Mwangome M, Ngari M, Dolan C. Children concurrently wasted and stunted: A meta-analysis of prevalence data of children 6-59 months from 84 countries. Matern Child Nutr. 2018 Apr;14(2):e12516. doi: 10.1111/mcn.12516. Epub 2017 Sep 25.

    PMID: 28944990BACKGROUND

  • Schofield C, Ashworth A. Why have mortality rates for severe malnutrition remained so high? Bull World Health Organ. 1996;74(2):223-9.

    PMID: 8706239BACKGROUND

  • Lelijveld N, Godbout C, Krietemeyer D, Los A, Wegner D, Hendrixson DT, Bandsma R, Koroma A, Manary M. Treating high-risk moderate acute malnutrition using therapeutic food compared with nutrition counseling (Hi-MAM Study): a cluster-randomized controlled trial. Am J Clin Nutr. 2021 Sep 1;114(3):955-964. doi: 10.1093/ajcn/nqab137.

    PMID: 33963734DERIVED

Related Links

MeSH Terms

Conditions

Malnutrition

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mark Manary, MD

    Washington University School of Medicine in St. Louis

    PRINCIPAL INVESTIGATOR

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

July 31, 2018

First Posted

August 27, 2018

Study Start

November 13, 2018

Primary Completion

June 5, 2020

Study Completion

June 5, 2020

Last Updated

September 1, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

SI(1)