Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-02-20 @ 4:49 PM
Study NCT ID:
NCT02760095
Status:
COMPLETED
Last Update Posted:
2019-07-01
First Post:
2015-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of EED on Zn Absorption and Retention in Children From a Standard Dose
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014802', 'term': 'Vitamin A Deficiency'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Spot urine samples x 4 days; complete fecal collections x 4 days; blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-27', 'studyFirstSubmitDate': '2015-07-24', 'studyFirstSubmitQcDate': '2016-04-29', 'lastUpdatePostDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absorption of zinc (AZ) from standard dose', 'timeFrame': '1 day', 'description': 'Absorption of zinc from standard 3 mg dose will be measured using zinc isotope tracer methods'}, {'measure': 'Endogenous fecal zinc (EFZ)', 'timeFrame': '4 days', 'description': 'EFZ measured from zinc isotope ratios in complete fecal collections'}, {'measure': 'Vitamin A absorption', 'timeFrame': '1 day', 'description': 'Absorption efficiency of retinol will be measured by isotope ratios in blood'}], 'secondaryOutcomes': [{'measure': 'Plasma zinc', 'timeFrame': '1 day', 'description': 'Plasma zinc concentration'}, {'measure': 'Alkaline phosphatase', 'timeFrame': '1 day'}, {'measure': 'Serum retinol', 'timeFrame': '1 day'}, {'measure': 'Methyl malonic acid', 'timeFrame': '1 day', 'description': 'serum'}, {'measure': 'Vitamin B12', 'timeFrame': '1 day'}, {'measure': 'Serum ferritin', 'timeFrame': '1 day'}, {'measure': 'Soluble transferrin receptors', 'timeFrame': '1 day'}, {'measure': 'C-reactive Protein (CRP)', 'timeFrame': '1 day'}, {'measure': 'Alpha-Glycoprotein (AGP)', 'timeFrame': '1 day'}, {'measure': 'Tumor necrosis factor (TNF) alpha', 'timeFrame': '1 day'}, {'measure': 'Serum endocab', 'timeFrame': '1 day'}, {'measure': 'Fecal neopterin', 'timeFrame': '1 day'}, {'measure': 'Myeloperoxidase', 'timeFrame': '1 day'}, {'measure': 'Alpha 1 antitrypsin', 'timeFrame': '1 day'}, {'measure': 'Calprotectin', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['environmental enteric dysfunction', 'environmental enteropathy', 'zinc', 'vitamin A', 'Bangladesh'], 'conditions': ['Environmental Enteric Dysfunction', 'Zinc Deficiency', 'Vitamin A Deficiency']}, 'referencesModule': {'references': [{'pmid': '31033623', 'type': 'DERIVED', 'citation': 'Mondal P, Long JM, Westcott JE, Islam MM, Ahmed M, Mahfuz M, Ahmed T, Miller LV, Krebs NF. Zinc Absorption and Endogenous Fecal Zinc Losses in Bangladeshi Toddlers at Risk for Environmental Enteric Dysfunction. J Pediatr Gastroenterol Nutr. 2019 Jun;68(6):874-879. doi: 10.1097/MPG.0000000000002361.'}]}, 'descriptionModule': {'briefSummary': 'The overall objective is to determine the impact of EED on zinc absorption and homeostasis, and its impact on the absorptive capacity of vitamin A absorption of young children (18-24 months of age) in an austere setting with high rates of diarrhea, stunting, and micro-nutrient deficiencies.', 'detailedDescription': 'Participating children are screened for EED using the lactulose:mannitol ratio test and assigned to one of two groups: +EED or -EED. All participants will be given standard, physiological dose of 3 mg zinc sulfate with a zinc stable isotope tracer on study day 8.\n\nOn study day 11, 0.5 mg of 13C10-retinyl-acetate will be administered orally to all participants.\n\nSpot urine samples will be collected twice daily from study days 11-14. Complete fecal collections will be obtained for days 11-14. Duplicate diets of all foods consumed will be collected on days 11-14. On study day 14, a blood sample will be taken for analysis of vitamin A isotope status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '18 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Toddlers aged 18-24 mos living in Dhaka, Bangladesh', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Absence of apparent health problems that would impair ability to consume regular diet, to tolerate zinc supplements, or to comply with demands of metabolic studies\n* Length for age Z-score (LAZ) between -1.5 to -3.0\n* Hemoglobin (Hgb) ≥ 8\n\nExclusion Criteria:\n\n* Outside age range\n* Hgb \\< 8\n* Chronic illness\n* Recent diarrhea (within past 2 weeks, treated with supplemental zinc)\n* Severe stunting and/or severe acute malnutrition (SAM): LAZ \\<-3; Weight-for-age Z-score (WHZ) \\<-3 or mid-upper arm circumference (MUAC) \\< 115 or edema'}, 'identificationModule': {'nctId': 'NCT02760095', 'acronym': 'ZEED1', 'briefTitle': 'Effects of EED on Zn Absorption and Retention in Children From a Standard Dose', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Effects of Environmental Enteric Dysfunction (EED) on Zinc (Zn) Absorption and Retention in Young Children: Study 1 - Absorption of Zn and Vitamin A From a Standard Dose', 'orgStudyIdInfo': {'id': '14-2430A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with EED', 'description': 'Children are placed in this arm if they screen positive for EED using the urinary lactulose:mannitol (L:M) recovery ratio. Children will receive a one-time 3 mg standard dose of zinc sulfate with stable isotope zinc tracer and 0.5 mg standard dose of 13C10-retinyl-acetate (vitamin A isotope).', 'interventionNames': ['Drug: 3 mg zinc sulfate supplement', 'Drug: 0.5 mg of 13C10-retinyl-acetate']}, {'label': 'Children without EED', 'description': 'Children are placed in this arm if they screen negative for EED using the urinary lactulose:mannitol (L:M) recovery ratio. Children will receive a one-time 3 mg standard dose of zinc sulfate with stable isotope zinc tracer and 0.5 mg standard dose of 13C10-retinyl-acetate (vitamin A isotope).', 'interventionNames': ['Drug: 3 mg zinc sulfate supplement', 'Drug: 0.5 mg of 13C10-retinyl-acetate']}], 'interventions': [{'name': '3 mg zinc sulfate supplement', 'type': 'DRUG', 'armGroupLabels': ['Children with EED', 'Children without EED']}, {'name': '0.5 mg of 13C10-retinyl-acetate', 'type': 'DRUG', 'otherNames': ['Vitamin A isotope'], 'armGroupLabels': ['Children with EED', 'Children without EED']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver School of Medicine', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'icddr,b (International Centre for Diarrheal Disease Research, Bangladesh', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'overallOfficials': [{'name': 'Nancy F Krebs, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'International Centre for Diarrhoeal Disease Research, Bangladesh', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}