Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-31 @ 3:02 AM
Study NCT ID:
NCT01593033
Status:
COMPLETED
Last Update Posted:
2013-01-14
First Post:
2012-05-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Micronutrient Supplementation and Fish Oil + Micronutrient Supplementation in the Treatment of Environmental Enteropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005395', 'term': 'Fish Oils'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-11', 'studyFirstSubmitDate': '2012-05-03', 'studyFirstSubmitQcDate': '2012-05-03', 'lastUpdatePostDateStruct': {'date': '2013-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in urine lactulose:mannitol (L:M) ratio following therapy course.', 'timeFrame': '3 months, 6 months'}], 'secondaryOutcomes': [{'measure': 'Changes in the expression of several fecal mRNAs', 'timeFrame': '3 months, 6 months'}, {'measure': 'Changes in amounts of lactulose and mannitol excreted in the urine as a percentage of the amounts ingested', 'timeFrame': '3 months, 6 months'}, {'measure': 'Change in height', 'timeFrame': '3 month, 6 month'}]}, 'conditionsModule': {'conditions': ['Environmental Enteropathy']}, 'referencesModule': {'references': [{'pmid': '25411039', 'type': 'DERIVED', 'citation': 'Smith HE, Ryan KN, Stephenson KB, Westcott C, Thakwalakwa C, Maleta K, Cheng JY, Brenna JT, Shulman RJ, Trehan I, Manary MJ. Multiple micronutrient supplementation transiently ameliorates environmental enteropathy in Malawian children aged 12-35 months in a randomized controlled clinical trial. J Nutr. 2014 Dec;144(12):2059-65. doi: 10.3945/jn.114.201673. Epub 2014 Oct 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the therapeutic effectiveness of micronutrients (full RDA) and micronutrients + fish oil as separate interventions in restoring normal gut absorptive and immunological function as measured by the dual sugar permeability test and additional biomarkers in 1-3 year old rural Malawian children at high risk for Environmental Enteropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1-3 years of age\n* Lives in study villages\n* Will not move in next 6 months\n* Caregiver willing to give intervention daily for 6 months\n\nExclusion Criteria:\n\n* Unable to drink 20 mL of sugar water\n* Demonstrating evidence of severe acute malnutrition, WHZ \\< or = -3, presence of bi-pedal pitting edema\n* Apparent need for acute medical treatment for an illness or injury\n* Caregiver refusal to participate and return for 3 and 6 month follow-ups'}, 'identificationModule': {'nctId': 'NCT01593033', 'briefTitle': 'Effectiveness of Micronutrient Supplementation and Fish Oil + Micronutrient Supplementation in the Treatment of Environmental Enteropathy', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Randomized, Double-blind, Placebo-controlled Trial Evaluating the Impact of Micronutrient Supplementation and Fish Oil + Micronutrient Supplementation in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children', 'orgStudyIdInfo': {'id': 'MJM - Fish Oil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fish oil and Micronutrient Supplementation', 'interventionNames': ['Dietary Supplement: Fish oil and Micronutrient Supplementation']}, {'type': 'EXPERIMENTAL', 'label': 'Micronutrient Supplementation', 'interventionNames': ['Dietary Supplement: Micronutrient Supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Fish oil and Micronutrient Supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': '0.9 mL highly purified fish oil (200 mg docosahexaenoic acid, 300 mg eicosapentaenoic acid) to be given daily for 6 months\n\n1 RDA of all known micronutrients needed for normal child growth in powder form to be given daily for 6 months', 'armGroupLabels': ['Fish oil and Micronutrient Supplementation']}, {'name': 'Micronutrient Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 RDA all known micronutrients needed for normal child growth to be given daily in powder form for 6 months 0.9 mL palm oil given daily for 6 months', 'armGroupLabels': ['Micronutrient Supplementation']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '10 g sugar in granule form to be given daily for 6 months 0.9 mL palm oil to be given daily for 6 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Blantyre', 'country': 'Malawi', 'facility': 'Saint Louis Nutrition Project', 'geoPoint': {'lat': -15.78499, 'lon': 35.00854}}], 'overallOfficials': [{'name': 'Mark J Manary, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}