Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2026-03-03 @ 4:42 PM
Study NCT ID:
NCT03989700
Status:
UNKNOWN
Last Update Posted:
2019-06-20
First Post:
2019-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Thiamin Supplementation on Thiamin Status in Children With Heart Disease Receiving Diuretic Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001602', 'term': 'Beriberi'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013832', 'term': 'Thiamine Deficiency'}, {'id': 'D014804', 'term': 'Vitamin B Deficiency'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013831', 'term': 'Thiamine'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1. Enroll children with heart disease receiving diuretic drugs\n2. Evaluate thiamin status by measuring thiamin pyrophosphate effect, cardiac function by echocardiography\n3. Randomize subjects into 3 arms: 2 groups receive different dosages of thiamin supplementation and 1 group receives placebo for 4 weeks\n4. After 4 weeks, thiamin status and echocardiography are evaluated.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-19', 'studyFirstSubmitDate': '2019-06-14', 'studyFirstSubmitQcDate': '2019-06-14', 'lastUpdatePostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in thiamin pyrophosphate effect', 'timeFrame': '4 weeks', 'description': 'Compare percentage change in thiamin pyrophosphate effect before and after thiamin supplementation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diuretic drugs', 'Thiamin deficiency'], 'conditions': ['Heart Diseases']}, 'referencesModule': {'references': [{'pmid': '23910704', 'type': 'BACKGROUND', 'citation': "DiNicolantonio JJ, Niazi AK, Lavie CJ, O'Keefe JH, Ventura HO. Thiamine supplementation for the treatment of heart failure: a review of the literature. Congest Heart Fail. 2013 Jul-Aug;19(4):214-22. doi: 10.1111/chf.12037."}, {'pmid': '26899752', 'type': 'BACKGROUND', 'citation': 'Katta N, Balla S, Alpert MA. Does Long-Term Furosemide Therapy Cause Thiamine Deficiency in Patients with Heart Failure? A Focused Review. Am J Med. 2016 Jul;129(7):753.e7-753.e11. doi: 10.1016/j.amjmed.2016.01.037. Epub 2016 Feb 18.'}, {'pmid': '11127971', 'type': 'BACKGROUND', 'citation': 'Suter PM, Vetter W. Diuretics and vitamin B1: are diuretics a risk factor for thiamin malnutrition? Nutr Rev. 2000 Oct;58(10):319-23. doi: 10.1111/j.1753-4887.2000.tb01827.x.'}, {'pmid': '7722187', 'type': 'BACKGROUND', 'citation': 'Brady JA, Rock CL, Horneffer MR. Thiamin status, diuretic medications, and the management of congestive heart failure. J Am Diet Assoc. 1995 May;95(5):541-4. doi: 10.1016/S0002-8223(95)00148-4.'}, {'pmid': '14712323', 'type': 'BACKGROUND', 'citation': 'Zenuk C, Healey J, Donnelly J, Vaillancourt R, Almalki Y, Smith S. Thiamine deficiency in congestive heart failure patients receiving long term furosemide therapy. Can J Clin Pharmacol. 2003 Winter;10(4):184-8.'}, {'pmid': '10850940', 'type': 'BACKGROUND', 'citation': 'Shamir R, Dagan O, Abramovitch D, Abramovitch T, Vidne BA, Dinari G. Thiamine deficiency in children with congenital heart disease before and after corrective surgery. JPEN J Parenter Enteral Nutr. 2000 May-Jun;24(3):154-8. doi: 10.1177/0148607100024003154.'}, {'pmid': '22057652', 'type': 'BACKGROUND', 'citation': 'Schoenenberger AW, Schoenenberger-Berzins R, der Maur CA, Suter PM, Vergopoulos A, Erne P. Thiamine supplementation in symptomatic chronic heart failure: a randomized, double-blind, placebo-controlled, cross-over pilot study. Clin Res Cardiol. 2012 Mar;101(3):159-64. doi: 10.1007/s00392-011-0376-2. Epub 2011 Nov 5.'}, {'pmid': '7733128', 'type': 'BACKGROUND', 'citation': 'Shimon I, Almog S, Vered Z, Seligmann H, Shefi M, Peleg E, Rosenthal T, Motro M, Halkin H, Ezra D. Improved left ventricular function after thiamine supplementation in patients with congestive heart failure receiving long-term furosemide therapy. Am J Med. 1995 May;98(5):485-90. doi: 10.1016/s0002-9343(99)80349-0.'}, {'pmid': '7214397', 'type': 'BACKGROUND', 'citation': 'Yui Y, Itokawa Y, Kawai C. Furosemide-induced thiamine deficiency. Cardiovasc Res. 1980 Sep;14(9):537-40. doi: 10.1093/cvr/14.9.537.'}, {'pmid': '28482838', 'type': 'BACKGROUND', 'citation': 'LeBlanc JG, Chain F, Martin R, Bermudez-Humaran LG, Courau S, Langella P. Beneficial effects on host energy metabolism of short-chain fatty acids and vitamins produced by commensal and probiotic bacteria. Microb Cell Fact. 2017 May 8;16(1):79. doi: 10.1186/s12934-017-0691-z.'}, {'pmid': '20040703', 'type': 'BACKGROUND', 'citation': 'Rogovik AL, Vohra S, Goldman RD. Safety considerations and potential interactions of vitamins: should vitamins be considered drugs? Ann Pharmacother. 2010 Feb;44(2):311-24. doi: 10.1345/aph.1M238. Epub 2009 Dec 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine effect of thiamin supplementation on thiamin status by measuring thiamin pyrophosphate effect in children with heart disease receiving diuretic drugs.', 'detailedDescription': 'Children with heart disease receiving diuretic drugs are susceptible to thiamin deficiency due to increase renal loss. Thiamin deficiency causes abnormal cardiac contraction resulting in heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 1 month old to 15 years old diagnosed as heart disease\n* Receiving diuretic drugs at least 1 month\n\nExclusion Criteria:\n\n* Receiving thiamin-containing vitamins\n* Receiving hemodialysis or peritoneal dialysis\n* Having problems of intestinal malabsorption, chronic lung disease, red blood cell abnormality such as thalassemia , abnormal hemoglobin typing, G6PD deficiency\n* Receiving thiamin-producing probiotics\n* Receiving inotropic drugs\n* Severe anemia: Hb \\< 7 g/dL'}, 'identificationModule': {'nctId': 'NCT03989700', 'briefTitle': 'Effect of Thiamin Supplementation on Thiamin Status in Children With Heart Disease Receiving Diuretic Drugs', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Effect of Thiamin Supplementation on Thiamin Status in Children With Heart Disease Receiving Diuretic Drugs: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Si364/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low dose', 'description': 'Low dose of thiamin supplementation', 'interventionNames': ['Drug: Thiamine Mononitrate']}, {'type': 'EXPERIMENTAL', 'label': 'High dose', 'description': 'High dose of thiamin supplementation', 'interventionNames': ['Drug: Thiamine Mononitrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo supplementation', 'interventionNames': ['Drug: Thiamine Mononitrate']}], 'interventions': [{'name': 'Thiamine Mononitrate', 'type': 'DRUG', 'otherNames': ['Vitamin B1'], 'description': 'Low dose group: thaimine mononitrate 25 mg/day per oral daily for 4 weeks High dose group: thaimine mononitrate 50 mg/day per oral daily for 4 weeks Placebo group: placebo 25 mg/day per oral daily for 4 weeks', 'armGroupLabels': ['High dose', 'Low dose', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Medicine Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Narumon Densupsoontorn, MD', 'role': 'CONTACT', 'email': 'narumon.den@mahidol.ac.th', 'phone': '662 4197000', 'phoneExt': '5947'}], 'overallOfficials': [{'name': 'Narumon Densupsoontorn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Siriraj Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Narumon Densupsoontorn', 'investigatorAffiliation': 'Mahidol University'}}}}