Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-01 @ 3:41 PM
Study NCT ID:
NCT00429351
Status:
COMPLETED
Last Update Posted:
2020-02-26
First Post:
2007-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aromatic Amino Acid Metabolism in the Pathogenesis of Kwashiorkor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007732', 'term': 'Kwashiorkor'}], 'ancestors': [{'id': 'D000067011', 'term': 'Severe Acute Malnutrition'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'plasma, expired breath'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-24', 'studyFirstSubmitDate': '2007-01-30', 'studyFirstSubmitQcDate': '2007-01-30', 'lastUpdatePostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-01-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Kwashiorkor']}, 'descriptionModule': {'briefSummary': 'This research may explain whether a shortage of three special compounds called aromatic amino acids is responsible for the severe illness and high death rate of children with the kwashiorkor type of malnutrition and whether supplying adequate amounts of these compounds in the treatment diet will speed up recovery from this condition. We propose that decreased availability of the aromatic amino acids may be the reason why children with kwashiorkor are sicker and more difficult to treat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '82 children aged 6 to 18 months and diagnosed with severe protein-energy malnutrition. By the Wellcome Classification patients will have marasmus (\\< 60 % weight/age and no edema), marasmic-kwashiorkor (\\< 60 % weight/age plus edema) or kwashiorkor (\\< 80 % weight/age plus edema)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Malnourished children between 6 to 18 months of age.\n* To standardize for degree of malnutrition, only patients whose weight is \\< 80 % of that expected for age will be enrolled. By the Wellcome Classification (22), enrolled patients will have marasmus (\\< 60 % weight/age and no edema), marasmic-kwashiorkor (\\< 60 % weight/age plus edema) or kwashiorkor (\\< 80 % weight/age plus edema).\n* Presence of infection at admission. Infection will be defined by the presence of two or more of the following: Leukocyte count \\>11,000 cells/dl, temperature at admission \\> 99 oF, positive blood or urine cultures.\n\nExclusion Criteria:\n\n* Criteria for exclusion will include presence of cardiovascular, hepatic, renal, gastrointestinal, metabolic disease or HIV/AIDS.'}, 'identificationModule': {'nctId': 'NCT00429351', 'briefTitle': 'Aromatic Amino Acid Metabolism in the Pathogenesis of Kwashiorkor', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'orgStudyIdInfo': {'id': 'H-16233'}, 'secondaryIdInfos': [{'id': 'R01DK075018', 'link': 'https://reporter.nih.gov/quickSearch/R01DK075018', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Kingston-7', 'city': 'Mona', 'state': 'Kingston', 'country': 'Jamaica', 'facility': 'Tropical Metabolism Research Unit, University of the West Indies'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Pediatrics-Nutrition', 'investigatorFullName': 'Farook Jahoor', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}