Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-02-26 @ 2:14 AM
Study NCT ID:
NCT02838303
Status:
COMPLETED
Last Update Posted:
2023-07-28
First Post:
2016-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Self-reported Symptoms as a Proxy for Acute Organophosphate Poisoning Among Nepali Farmers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D062025', 'term': 'Organophosphate Poisoning'}], 'ancestors': [{'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010755', 'term': 'Organophosphates'}, {'id': 'D061046', 'term': 'Biological Control Agents'}], 'ancestors': [{'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-27', 'studyFirstSubmitDate': '2016-07-14', 'studyFirstSubmitQcDate': '2016-07-17', 'lastUpdatePostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in self-reported acute organophosphate poisoning symptoms from baseline to follow up', 'timeFrame': 'Obtained just before (baseline) and 30 minutes after (baseline) each spray session', 'description': "Obtained using a structured questionnaire interview. The definition of symptoms was based on WHO's standardized list of clinical presentations of acute organophosphate poisoning."}, {'measure': 'Change in Plasma Cholinesterase (PchE) activity from baseline to follow up', 'timeFrame': 'Obtained just before (baseline) and 30 minutes after (baseline) each spray session', 'description': 'PchE activity was measured with a blood test using a Test-mate Che Cholinesterase System (Model 400) with a PchE Plasma Cholinesterase Assay Kit (Model 470).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Organophosphate Poisoning']}, 'referencesModule': {'references': [{'pmid': '27964728', 'type': 'DERIVED', 'citation': 'Kofod DH, Jors E, Varma A, Bhatta S, Thomsen JF. The use of self-reported symptoms as a proxy for acute organophosphate poisoning after exposure to chlorpyrifos 50% plus cypermethrin 5% among Nepali farmers: a randomized, double-blind, placebo-controlled, crossover study. Environ Health. 2016 Dec 13;15(1):122. doi: 10.1186/s12940-016-0205-1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate self-reported symptoms as a proxy for acute organophosphate poisoning by examining self-reported acute organophosphate poisoning symptoms and PchE activity in response to occupational acute organophosphate exposure among farmers in Nepal.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* male\n* minimum age 18 years\n* hand pressured backpack sprayer usage\n* used to spray with moderately to extremely hazardous pesticides according to the World Health Organization's (WHO) Pesticide Hazard Classification\n\nExclusion Criteria:\n\n* usual personal protective equipment use (respirator/mask with particulate filter, face shield, googles, gloves, boots, plastic poncho)\n* unwilling to stay pesticide-free seven days prior to each of the two spray sessions\n* medical conditions interfering with PchE activity (liver disease, acute infection, chronic malnutrition, heart attack, cancer, obstructive jaundice, inflammation caused by various diseases, or use of pyridostigmine drugs)"}, 'identificationModule': {'nctId': 'NCT02838303', 'briefTitle': 'The Use of Self-reported Symptoms as a Proxy for Acute Organophosphate Poisoning Among Nepali Farmers', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'The Use of Self-reported Symptoms as a Proxy for Acute Organophosphate Poisoning Among Nepali Farmers: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study', 'orgStudyIdInfo': {'id': '12205-01-57-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group A', 'description': 'Initial spray session: organophosphate. Crossover spray session: placebo', 'interventionNames': ['Other: Organophosphate', 'Other: Placebo']}, {'type': 'OTHER', 'label': 'Group B', 'description': 'Initial spray session: placebo. Crossover spray session: organophosphate', 'interventionNames': ['Other: Organophosphate', 'Other: Placebo']}], 'interventions': [{'name': 'Organophosphate', 'type': 'OTHER', 'description': 'Chlorpyrifos 50% plus cypermethrin 5%, WHO Class II: Moderately hazardous', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Biopesticide'], 'description': 'Multineem, WHO Class U: Unlikely to present acute hazard in normal use', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dea H. Kofod, MB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Occupational and Environmental Medicine, Bispebjerg Frederiksberg Hospital, University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Augustinus Fonden', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MB', 'investigatorFullName': 'Dea Haagensen Kofod', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}