Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-02-02 @ 5:13 AM
Study NCT ID:
NCT03647150
Status:
COMPLETED
Last Update Posted:
2020-09-01
First Post:
2018-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000658', 'term': 'Amoxicillin'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1322}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-29', 'studyFirstSubmitDate': '2018-07-31', 'studyFirstSubmitQcDate': '2018-08-23', 'lastUpdatePostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery from moderate acute malnutrition (MAM)', 'timeFrame': 'up to 12 weeks of treatment', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Participant survival rates', 'timeFrame': 'Duration of the study 24 weeks post-enrollment', 'description': 'Proportion of participants survival rates during the study'}, {'measure': 'Participants deterioration to severe acute malnutrition(SAM)', 'timeFrame': 'Duration of the study 24 weeks post-enrollment', 'description': 'Proportion of participants that deteriorate from moderate acute malnutrition(MAM) to severe acute malnutrition(SAM). SAM is defined at mid-upper arm circumference(MUAC)\\<11.5 or presence of oedema.'}, {'measure': 'Participants that remain or become underweight using weight for age z-score', 'timeFrame': '24 weeks post-enrollment', 'description': 'the difference between the weight for age z-score(WAZ) from enrollment to 24 weeks post-enrollment'}, {'measure': 'Participants that remain or become Stunted', 'timeFrame': '24 weeks post-enrollment', 'description': 'the difference between length for age z-score(LAZ) from enrollment to 24 weeks post enrollment'}, {'measure': 'Participants that remain or become Wasted', 'timeFrame': '24 weeks post-enrollment', 'description': 'the difference between weight for length z-score(WHL) from enrollment to 24 weeks post enrollment'}, {'measure': 'Eye tracking performance for cognitive development', 'timeFrame': '24 weeks post enrollment', 'description': 'the difference between the eye tracking performance from enrollment to 24 weeks post enrollment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malnutrition']}, 'referencesModule': {'references': [{'pmid': '4839581', 'type': 'BACKGROUND', 'citation': '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': '24564235', 'type': 'BACKGROUND', 'citation': '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': '23256140', 'type': 'BACKGROUND', 'citation': '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': '26423737', 'type': 'BACKGROUND', 'citation': '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': '17032722', 'type': 'BACKGROUND', 'citation': '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': '28944990', 'type': 'BACKGROUND', 'citation': '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': '8706239', 'type': 'BACKGROUND', 'citation': 'Schofield C, Ashworth A. Why have mortality rates for severe malnutrition remained so high? Bull World Health Organ. 1996;74(2):223-9.'}, {'pmid': '36967172', 'type': 'DERIVED', 'citation': 'Rajabi T, Schell SK, Agapova SE, Hassan A, Zalta M, Wegner DR, Callaghan-Gillespie M, Koroma A, Kamara MT, Manary MJ, Stephenson KB. Supplementary Feeding of Moderately Wasted Children in Sierra Leone Reduces Severe Acute Malnutrition and Death When Compared with Nutrition Counseling: A Retrospective Cohort Study. J Nutr. 2022 Apr;152(4):1149-1158. doi: 10.1093/jn/nxab451. Epub 2023 Feb 18.'}, {'pmid': '33963734', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://esa.un.org/unpd/wpp/DataQuery/', 'label': 'United Nations Department of Economic and Social Affairs, P.D. World Population Prospectus 2017. 2017'}, {'url': 'http://www.who.int/maternal_child_adolescent/documents/IMCI_chartbooklet/en/', 'label': 'WHO. IMCI chart booklet. 2014'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "This is a cluster-randomized controlled trial taking place in 20 community clinics providing malnutrition care in Sierra Leone.\n\nAll participants will be children aged 6-59 months. Control participants will have moderate acute malnutrition (MAM), defined as mid-upper arm circumference (MUAC) 11.5-\\<12.5. High Risk MAM will be defined with a MUAC 11.5 to \\<11.9 or WAZ\\<-3.5 or Mother not the caretaker or not breastfeeding at \\<2 years old. Low risk MAM defined with a MUAC 11.9 to \\<12.5 with no risk factors.\n\nControl group and low risk group caregiver's will received nutrition education via mother care groups every two weeks for 6 weeks and will be followed up 12 and 24 weeks post-enrollment.\n\nHigh risk group will receive 1 week supply of amoxicillin at enrollment and 1 sachet of RUTF per day till MUAC is equal to or greater than 12.5 or up to 12 weeks of treatment. Their caregiver will also receive nutrition education via the mother care groups. The investigators will also follow up with the participant at 12 and 24 weeks post-enrollment.\n\nA subset of the participants in each group will also be enrolled in a cognitive development substudy were the investigators will be using a eye tracking performance assessment. Investigators will also enroll health adult participants for eye tracking assessment. Adult data will be used as a reference when interpreting results."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* uncomplicated MAM (based on MUAC equal to or greater than 11.5 cm and \\<12.5)\n\nExclusion Criteria:\n\n* currently involved in another research trial or feeding program\n* medical complication such as oedema, severe nausea/vomiting, severe dehydration, or severe pneumonia\n* have a diagnosed or visible sign of developmental delay\n* have a history of peanut or milk allergy'}, 'identificationModule': {'nctId': 'NCT03647150', 'acronym': 'Hi-MAM', 'briefTitle': 'Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria (Hi-MAM Study): A Cluster-randomized Controlled Trial Protocol', 'orgStudyIdInfo': {'id': '201807153'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Moderate Acute Malnutrition (MAM)', 'description': '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.', 'interventionNames': ['Behavioral: Mother Care group']}, {'type': 'EXPERIMENTAL', 'label': 'High Risk Moderate Acute Malnutrition (MAM)', 'description': '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.', 'interventionNames': ['Drug: amoxicillin', 'Dietary Supplement: Ready-to-use therapeutic food (RUTF)', 'Behavioral: Mother Care group']}], 'interventions': [{'name': 'amoxicillin', 'type': 'DRUG', 'description': 'At enrollment the child will receive a 1 week course of amoxicillin', 'armGroupLabels': ['High Risk Moderate Acute Malnutrition (MAM)']}, {'name': 'Ready-to-use therapeutic food (RUTF)', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 sachet RUTF per day (508 calories) till child MUAC is greater than 12.4 cm or 12 weeks have elapsed', 'armGroupLabels': ['High Risk Moderate Acute Malnutrition (MAM)']}, {'name': 'Mother Care group', 'type': 'BEHAVIORAL', 'description': 'Nutrition education via mother care groups lead by a respected elder in the local community', 'armGroupLabels': ['High Risk Moderate Acute Malnutrition (MAM)', 'Moderate Acute Malnutrition (MAM)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Freetown', 'country': 'Sierra Leone', 'facility': 'Project Peanut Butter', 'geoPoint': {'lat': 8.48714, 'lon': -13.2356}}], 'overallOfficials': [{'name': 'Mark Manary, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine in St. Louis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre for Global Child Health, Hospital for Sick Kids, Toronto, Canada', 'class': 'UNKNOWN'}, {'name': 'Department of Psychology, University of Tampere, Finland', 'class': 'UNKNOWN'}, {'name': 'Project Peanut Butter, Sierra Leone', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}