Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-28 @ 3:58 PM
Study NCT ID:
NCT01154803
Status:
COMPLETED
Last Update Posted:
2013-10-16
First Post:
2010-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D008288', 'term': 'Malaria'}, {'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D003289', 'term': 'Convalescence'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2213}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-15', 'studyFirstSubmitDate': '2010-06-30', 'studyFirstSubmitQcDate': '2010-06-30', 'lastUpdatePostDateStruct': {'date': '2013-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '"negative nutritional outcome" of a child', 'timeFrame': '6 months follow-up', 'description': 'The incidence of a negative nutritional outcome will be defined in two different ways according to the baseline nutritional status.\n\ni) for children with no malnourishment at time of entry into study, "negative nutritional outcome" is defined as progression to moderate or severe malnourishment ii) for children with moderate malnourishment at time of entry into study, "negative nutritional outcome" is defined as loss of ³10% of baseline weight or progression to severe malnourishment, whichever is reached first.'}], 'secondaryOutcomes': [{'measure': 'Number of new events of a study disease', 'timeFrame': '6 months', 'description': 'study disease: malaria, diarrhoea, and LRTI'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Supplementation', 'RUTF', 'Micronutrients', 'Plumpynut', 'Mixme', 'sprinkles', 'convalescence', 'weight', 'morbidity'], 'conditions': ['Malnutrition', 'Malaria', 'Lower Respiratory Tract Infection', 'Diarrhoea']}, 'referencesModule': {'references': [{'pmid': '26859559', 'type': 'DERIVED', 'citation': 'van der Kam S, Salse-Ubach N, Roll S, Swarthout T, Gayton-Toyoshima S, Jiya NM, Matsumoto A, Shanks L. Effect of Short-Term Supplementation with Ready-to-Use Therapeutic Food or Micronutrients for Children after Illness for Prevention of Malnutrition: A Randomised Controlled Trial in Nigeria. PLoS Med. 2016 Feb 9;13(2):e1001952. doi: 10.1371/journal.pmed.1001952. eCollection 2016 Feb.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether 14 days nutritional supplementation with Ready to use therapeutic Food (RUTF) or micronutrients alone to children having an infection will prevent malnutrition and reduce the frequency of morbidity.', 'detailedDescription': 'Anorexia due to infection might lead to weight loss. In many settings total recovery is problematic what might result in a permanent lower weight. A short period high quality food supplementation could improve weight gain after an infection.\n\nA complete high quality food will be tested, but also micronutrients alone as there is no information on what children with an infection exactly need as a supplement.\n\nChildren aged 6-59 months presenting with diarrhoea, malaria or lower respiratory tract infection (LRTI) are provided for 2 weeks with\n\n* RUTF supplement (Plumpynut®) of 500 kcal/day\n* Multi-micronutrient powder (MNP)\n* Placebo to MNP\n\nThe followup period is 6 months. Anthropometric indicators and morbidity are assessed monthly. Participants are invited to attend the study clinic if any signs of disease are noticed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 6 to 59 months of age\n* Not malnourished or moderately acutely malnourished children\n* Diagnosis of malaria and/or diarrhoea and/or LRTI\n* Intending to remain in area for the duration of the 6 month follow-up\n* Living within approximately 60 minutes walking distance from the clinic\n* Informed consent from a guardian\\*\n\nExclusion Criteria:\n\n* Child is exclusively breastfeeding\n* Child is severely malnourished\n* Presence of 'General Danger Signs'\n* Presence of severe disease (including severe malaria, severe LRTI, severe diarrhoea)\n* Needing hospitalisation for any reason\n* Known history of allergy to the nutritional supplementation\n* Having a sibling enrolled in the study\\*"}, 'identificationModule': {'nctId': 'NCT01154803', 'briefTitle': 'Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection', 'organization': {'class': 'OTHER', 'fullName': 'Medecins Sans Frontieres, Netherlands'}, 'officialTitle': 'Effectiveness of Nutritional Supplementation (RUTF and Multi Micronutrient) in Preventing Malnutrition in Children 6-59 Months With Infection (Malaria, Pneumonia, Diarrhoea), a Randomized Controlled Trial in Nigeria', 'orgStudyIdInfo': {'id': 'MSF-nutcon02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ready to Use Therapeutic Food (RUTF)', 'description': '500 kcal /day for 2 weeks', 'interventionNames': ['Dietary Supplement: Ready to Use Therapeutic Food (RUTF)']}, {'type': 'EXPERIMENTAL', 'label': 'Micronutrient Powder (MNP)', 'description': '2 x 1 g sachets micronutrients /day for 2 weeks', 'interventionNames': ['Dietary Supplement: Micronutrient Powder (MNP)']}, {'type': 'NO_INTERVENTION', 'label': 'no supplement', 'description': 'no supplementation'}], 'interventions': [{'name': 'Ready to Use Therapeutic Food (RUTF)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['RUTF: Nutriset'], 'description': '1 sachet/day, 500 kcal and multi micronutrients (fortified high quality food(RUTF),for 2 weeks after an illness (malaria, diarrhoea, pneumonia)', 'armGroupLabels': ['Ready to Use Therapeutic Food (RUTF)']}, {'name': 'Micronutrient Powder (MNP)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['MNP: DSM'], 'description': '2 sachets / day for 14 days after an illness (diarrheoea, malaria, pneumonia)', 'armGroupLabels': ['Micronutrient Powder (MNP)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Goronyo', 'state': 'Sokoto State', 'country': 'Nigeria', 'facility': 'Goronyo health clinic outpatient department', 'geoPoint': {'lat': 13.44226, 'lon': 5.67234}}], 'overallOfficials': [{'name': 'Saskia Kam van der, Ir', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medecins Sans Frontieres Amsterdam'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medecins Sans Frontieres, Netherlands', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ir', 'investigatorFullName': 'Saskia van der Kam', 'investigatorAffiliation': 'Medecins Sans Frontieres, Netherlands'}}}}