Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-29 @ 9:43 PM
Study NCT ID:
NCT00890695
Status:
TERMINATED
Last Update Posted:
2017-08-14
First Post:
2009-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Supplementary Feeding During Infection Among Moderately Malnourished Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jberkley@kilifi.kemri-wellcome.org', 'phone': '+254 41 522535', 'title': 'Dr James Berkley', 'organization': 'KEMRI/Wellcome Trust Research Programme'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The trial was forced to stop early, 65 recruited. Analysis was inadequately powered to detect the changes in WHZ score and MUAC, the analysis of which had been originally planned for a sample size of 400.'}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': '1 RUSF', 'description': 'RUSF prescribed for the child for 4 weeks', 'otherNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': '2 Normal Diet', 'description': 'normal diet arm', 'otherNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'seriousNumAffected': 5}], 'seriousEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Weight for Height z Score at 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 RUSF', 'description': 'RUSF prescribed for the child for 4 weeks'}, {'id': 'OG001', 'title': '2 Normal Diet', 'description': 'normal diet arm'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.83', 'groupId': 'OG000', 'lowerLimit': '-2.15', 'upperLimit': '-1.51'}, {'value': '-1.44', 'groupId': 'OG001', 'lowerLimit': '-1.65', 'upperLimit': '-1.22'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'between enrolment and 4 weeks', 'description': 'The primary endpoint is weight for height z scores (WHZ), calculated from weight and height measures with reference to the WHO growth standards 2006. WHZ is a measure of wasting and acute malnutrition.\n\nA WHZ of zero is the median value of the reference population. Negative scores indicate undernutrition. Moderate and severe acute malnutrition are defined as WHZ\\<-2 and \\<-3 respectively. These correspond to 2 and 3 standard deviations below the reference median.\n\nOf all the anthropometric measures in regular use, WHZ and mid upper arm circumference (MUAC) have the strongest associations with infectious disease incidence and risk of death. WHZ is more appropriate than Weight for Age (WAZ), which is normally used in growth monitoring, because WAZ measures a combination of wasting and stunting (chronic malnutrition). Stunting is unlikely to be affected by short term intervention. WHZ is assessed by anthropometry, following WHO guidelines.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants recruited until trial was halted'}, {'type': 'SECONDARY', 'title': 'WHZ Score at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 RUSF', 'description': 'RUSF prescribed for the child for 4 weeks'}, {'id': 'OG001', 'title': '2 Normal Diet', 'description': 'normal diet arm'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.43', 'groupId': 'OG000', 'lowerLimit': '-1.68', 'upperLimit': '-1.18'}, {'value': '-1.29', 'groupId': 'OG001', 'lowerLimit': '-1.56', 'upperLimit': '-1.03'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'between enrolment and 3 months', 'unitOfMeasure': 'Z scores', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants recruited until trial halted'}, {'type': 'SECONDARY', 'title': 'MUAC for Age Z Score at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 RUSF', 'description': 'RUSF prescribed for the child for 4 weeks'}, {'id': 'OG001', 'title': '2 Normal Diet', 'description': 'normal diet arm'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.71', 'groupId': 'OG000', 'lowerLimit': '-1.99', 'upperLimit': '-1.43'}, {'value': '-1.62', 'groupId': 'OG001', 'lowerLimit': '-1.95', 'upperLimit': '-1.28'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'between enrolment and 4 weeks and at 3 months', 'unitOfMeasure': 'Z score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants recruited until trial halted'}, {'type': 'SECONDARY', 'title': 'Development of Severe Malnutrition (WHZ Score <-3 and/or Kwashiorkor)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 RUSF', 'description': 'RUSF prescribed for the child for 4 weeks'}, {'id': 'OG001', 'title': '2 Normal Diet', 'description': 'normal diet arm'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 4 weeks and 3 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants recruited until trial halted'}, {'type': 'SECONDARY', 'title': 'Anemia (Hb <9.3g/dl)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 RUSF', 'description': 'RUSF prescribed for the child for 4 weeks'}, {'id': 'OG001', 'title': '2 Normal Diet', 'description': 'normal diet arm'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 4 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants recruited until trial halted'}, {'type': 'SECONDARY', 'title': 'Hospital Admission or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 RUSF', 'description': 'RUSF prescribed for the child for 4 weeks'}, {'id': 'OG001', 'title': '2 Normal Diet', 'description': 'normal diet arm'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from enrolment to 3 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants recruited until trial halted'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 Ready to Use Supplementary Food (RUSF)', 'description': "Products, Kenya. The RUSF composition is in accordance with recommended supplementary feed composition specified by the latest WHO expert consultation in 2008 reported by Golden et al. It is formulated to provide 507 kcal per 100g, 6% protein/energy ratio and 55% fat/energy ratio. Essential fatty acids contained are N-6 (linoleic acid) 6 kcal % and N-3 (o-linoleic) 0.3 kcal %. Vitamin and mineral premix (3%) will provide the currently recommended nutrient intake for moderately malnourished children of minerals (K, Na, Ca, P, Mg, Fe, Zn, Cu, Se, I, Mn, Cr, Mo, F), Vitamins (thiamine, riboflavin, pyridoxine, niacin, Vit B12, folic acid, Vit C, Biotin, Pantothenic acid, Vit A, Vit D,Vit E and Vit K).\n\ninitial visit. The amount supplied is based on the child's weight; the recommended energy supplement being 100kcal per kg per day which is equivalent to 25g RUSF per kg per day."}, {'id': 'FG001', 'title': '2 Normal Diet', 'description': 'For equity, parents or guardians of children in the usual diet arm are given 2 bags of maize meal (4Kg) for family consumption instead of RUSF. All parents and carers in both arms will also receive standard nutritional advice as specified in the current WHO IMCI handbook.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment was started on June 5 2009 and finished on October 8 2009. The study was terminated early because of an inadequate recruitment rate and because a donor-funded supplementary feeding programme targeting moderately malnourished children was started in September 2009.', 'preAssignmentDetails': 'Of the 7,132 sick children aged 6 months to 5 years seen in outpatients during the study period, 190 with a mid upper arm circumference (MUAC) \\<12.5cm were assessed for eligibility. Randomization was carried out on 65 children who were eligible and whose carers consented. 1 was withdrawn: weight for height Z score (WHZ) was found to be \\<-3.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1 RUSF', 'description': 'RUSF prescribed for the child for 4 weeks'}, {'id': 'BG001', 'title': '2 Normal Diet', 'description': 'normal diet arm'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '1.21', 'spread': '0.55', 'groupId': 'BG000'}, {'value': '1.15', 'spread': '0.46', 'groupId': 'BG001'}, {'value': '1.18', 'spread': '0.50', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Kenya', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open label randomised trial of nutrition products'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'whyStopped': 'New provision of supplementary feeds for moderately malnourished children', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-30', 'studyFirstSubmitDate': '2009-04-29', 'resultsFirstSubmitDate': '2013-01-15', 'studyFirstSubmitQcDate': '2009-04-29', 'lastUpdatePostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-06-17', 'studyFirstPostDateStruct': {'date': '2009-04-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight for Height z Score at 4 Weeks', 'timeFrame': 'between enrolment and 4 weeks', 'description': 'The primary endpoint is weight for height z scores (WHZ), calculated from weight and height measures with reference to the WHO growth standards 2006. WHZ is a measure of wasting and acute malnutrition.\n\nA WHZ of zero is the median value of the reference population. Negative scores indicate undernutrition. Moderate and severe acute malnutrition are defined as WHZ\\<-2 and \\<-3 respectively. These correspond to 2 and 3 standard deviations below the reference median.\n\nOf all the anthropometric measures in regular use, WHZ and mid upper arm circumference (MUAC) have the strongest associations with infectious disease incidence and risk of death. WHZ is more appropriate than Weight for Age (WAZ), which is normally used in growth monitoring, because WAZ measures a combination of wasting and stunting (chronic malnutrition). Stunting is unlikely to be affected by short term intervention. WHZ is assessed by anthropometry, following WHO guidelines.'}], 'secondaryOutcomes': [{'measure': 'WHZ Score at 3 Months', 'timeFrame': 'between enrolment and 3 months'}, {'measure': 'MUAC for Age Z Score at 3 Months', 'timeFrame': 'between enrolment and 4 weeks and at 3 months'}, {'measure': 'Development of Severe Malnutrition (WHZ Score <-3 and/or Kwashiorkor)', 'timeFrame': 'at 4 weeks and 3 months'}, {'measure': 'Anemia (Hb <9.3g/dl)', 'timeFrame': 'at 4 weeks'}, {'measure': 'Hospital Admission or Death', 'timeFrame': 'from enrolment to 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['supplementary feeding', 'moderate malnutrition', 'acute infection', 'developing country', 'children'], 'conditions': ['Malnutrition', 'Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether an outpatient-based strategy of short-term, ready to use supplementary food (RUSF) among moderately malnourished children with acute infections achieves greater improvement in anthropometric measurements of wasting than usual diet.', 'detailedDescription': 'Under nutrition is a contributing factor to at least a third of child deaths. Whilst severe malnutrition has the highest mortality risk, most malnutrition-related deaths are thought to be related to mild-moderate malnutrition.This is because moderate malnutrition is common, it directly increases the risk of death from common infectious diseases and may progress to severe malnutrition.\n\nMalnutrition may arise from poverty, food insecurity or inadequate nutrition being offered, and may begin early in life. Malnutrition is exacerbated by the multiple effects of infectious diseases such as gastroenteritis, pneumonia, malaria or HIV. All these common infections are associated with net protein loss with diversion of essential amino acids to producing acute phase and immune response proteins. Fever is associated with an increased resting energy expenditure of 7 to 13% per degree Centigrade. Activation of inflammatory cascades also causes reduced appetite and loss of lean tissue and fat. Acute infection is therefore associated with growth faltering, resulting in a vicious cycle. Acute infection is therefore a potential target for intervention to interrupt the vicious cycle between malnutrition and infection in children.\n\nThis study aims to evaluate a strategy of giving short-term RUSF as a supplement to usual diet at home, without daily observed feeding, administered through existing health services at Kilifi District Hospital, Kenya. RUSF has a very low moisture content and is essentially a lipid-enveloped paste, it is microbiologically stable with a long shelf life at tropical temperatures and preserves delicate micronutrients such as vitamin A.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 6 months to 5 years\n* Mid-upper arm circumference (MUAC) less than 12.5 cm\n* Resident in the Kilifi demographic surveillance (DSS) area\n* Presentation with acute (\\<5 days) illness including respiratory infection, malaria, diarrhoeal disease or other acute infection.\n* If admitted, admission of \\<5 days, recruited at discharge.\n\nExclusion Criteria:\n\n* Severe malnutrition (WHZ score \\< -3 or Kwashiorkor)\n* Requiring admission to hospital in the opinion of clinician\n* Known allergy to maize, soya, sorghum, milk or any RUSF components.\n* Consent declined\n* Underlying condition precluding assessment or inclusion\n* Any other reason why the consenting investigator thinks it is not appropriate for them to take part.'}, 'identificationModule': {'nctId': 'NCT00890695', 'acronym': 'MODMAL', 'briefTitle': 'Effectiveness of Supplementary Feeding During Infection Among Moderately Malnourished Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Randomized Controlled Trial of an Outpatient Strategy of Ready to Use Supplementary Food (RUSF) Among Moderately Malnourished Children With Acute Infection', 'orgStudyIdInfo': {'id': 'SSC 1415'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ready to use supplementary food (RUSF)', 'description': "The RUSF intervention consists of a food paste made of maize, soya, sorghum, vegetable oil, sugar, dried skim milk and vitamin/mineral premix, prepared by VALID Nutrition in collaboration with Insta Products, Kenya in accordance with composition specified by the latest WHO expert consultation in 2008. Children in the intervention arm receive 4 weeks supply of RUSF. The amount supplied is based on the child's weight to give energy supplement of 100kcal per kg per day, equivalent to 25g RUSF per kg per day.", 'interventionNames': ['Dietary Supplement: Ready to use supplementary food (RUSF)']}, {'type': 'NO_INTERVENTION', 'label': 'Normal diet (standard of care)', 'description': 'For equity, parents or guardians of children in the usual diet arm will be given 2 bags of maize meal(4Kg) for family consumption instead of RUSF. All parents and carers in both arms will also receive standard nutritional advice as specified in the current WHO IMCI handbook.'}], 'interventions': [{'name': 'Ready to use supplementary food (RUSF)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['RUSF'], 'description': "It is a strategy of detection of moderate malnutrition and providing advice and short term provision of a standard formulation of ready to use supplementary food (RUSF) for 4 weeks with appropriate counseling on its use.The amount supplied will be based on the child's weight; 100kcal per kg per day which is equivalent to 25g RUSF per kg per day.", 'armGroupLabels': ['Ready to use supplementary food (RUSF)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80108', 'city': 'Kilifi', 'state': 'Coast Province', 'country': 'Kenya', 'facility': 'Kemri Wellcome Trust Research Programme', 'geoPoint': {'lat': -3.63045, 'lon': 39.84992}}, {'zip': '80108', 'city': 'Kilifi', 'state': 'Coast', 'country': 'Kenya', 'facility': 'Kilifi District Hospital- OPD', 'geoPoint': {'lat': -3.63045, 'lon': 39.84992}}], 'overallOfficials': [{'name': 'James A Berkley', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KEMRI-Wellcome Trust Collaborative Research Program'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'James Berkley', 'investigatorAffiliation': 'University of Oxford'}}}}