Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-02-27 @ 10:39 AM
Study NCT ID:
NCT01501968
Status:
UNKNOWN
Last Update Posted:
2011-12-30
First Post:
2011-12-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003091', 'term': 'Colistin'}, {'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D011113', 'term': 'Polymyxins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D023181', 'term': 'Antimicrobial Cationic Peptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000089882', 'term': 'Antimicrobial Peptides'}, {'id': 'D052899', 'term': 'Pore Forming Cytotoxic Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-29', 'studyFirstSubmitDate': '2011-12-24', 'studyFirstSubmitQcDate': '2011-12-29', 'lastUpdatePostDateStruct': {'date': '2011-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients with Renal toxicity associated with colistin', 'timeFrame': 'up to 28 days', 'description': 'Renal toxicity associated with colistin according to RIFLE criteria'}], 'secondaryOutcomes': [{'measure': 'number of subjects with cure or improvement', 'timeFrame': 'up to 28 days', 'description': 'cure improvement worse death'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colistin', 'ascorbic acid', 'renal toxicity'], 'conditions': ['Drug Safety']}, 'referencesModule': {'references': [{'pmid': '25801556', 'type': 'DERIVED', 'citation': 'Sirijatuphat R, Limmahakhun S, Sirivatanauksorn V, Nation RL, Li J, Thamlikitkul V. Preliminary clinical study of the effect of ascorbic acid on colistin-associated nephrotoxicity. Antimicrob Agents Chemother. 2015;59(6):3224-32. doi: 10.1128/AAC.00280-15. Epub 2015 Mar 23.'}], 'seeAlsoLinks': [{'url': 'http://mahidol.ac.th', 'label': 'mahidol webpage'}]}, 'descriptionModule': {'briefSummary': 'Ascorbic acid (Vitamin C) could protect renal toxicity from colistin.', 'detailedDescription': 'Renal toxicity due to colistin therapy is common. Ascorbic acid (vitamin C) has been shown to prevent colistin associated renal toxicity in animals. This study is conducted to determine if acorbic acid can prevent Colistin-Associated Nephrotoxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years hospitalized patient who needs colistin for therapy of nosocomial infection\n\nExclusion Criteria:\n\n* pregnant woman\n* lactating mother\n* allergy to ascorbic acid\n* receiving non-steroidal antiinflammatory drugs (NSAID), aminoglycosides, vancomycin, cisplatin, amphotericin-B\n* received radiocontrast media within 1 week\n* renal stone\n* G-6-PD deficiency'}, 'identificationModule': {'nctId': 'NCT01501968', 'briefTitle': 'Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity', 'orgStudyIdInfo': {'id': 'CEU 2012-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Colistin', 'description': 'Colistimethate sodium 2.5-5mg/kg iv', 'interventionNames': ['Drug: Colistin']}, {'type': 'EXPERIMENTAL', 'label': 'Colistin + Ascorbic acid', 'description': 'Colistimethate sodium 2.5-5mg/kg iv and ascorbic acid 2 grams iv every 12 hours', 'interventionNames': ['Drug: Colistin + Ascorbic acid']}], 'interventions': [{'name': 'Colistin', 'type': 'DRUG', 'otherNames': ['Colistate'], 'description': 'Colistimethate sodium 2.5-5mg/kg iv per day', 'armGroupLabels': ['Colistin']}, {'name': 'Colistin + Ascorbic acid', 'type': 'DRUG', 'otherNames': ['vitamin c'], 'description': 'Colistimethate sodium 2.5-5mg/kg iv per day and ascorbic acid 2 grams iv q 12 hours', 'armGroupLabels': ['Colistin + Ascorbic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'contacts': [{'name': 'Visanu Thamlikitkul, MD', 'role': 'CONTACT', 'email': 'sivth@mahidol.ac.th', 'phone': '662-4197783'}, {'name': 'Visanu Thamlikitkul, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Siriraj Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Visanu Thamlikitkul, MD', 'role': 'CONTACT', 'email': 'sivth@mahidol.ac.th', 'phone': '662-419-7783'}], 'overallOfficials': [{'name': 'Visanu Thamlikitkul, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Siriraj Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Siriraj Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}