Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2026-01-25 @ 2:46 PM
Study NCT ID:
NCT01864057
Status:
COMPLETED
Last Update Posted:
2013-05-29
First Post:
2013-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001602', 'term': 'Beriberi'}, {'id': 'D013832', 'term': 'Thiamine Deficiency'}], 'ancestors': [{'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': 'C000712172', 'term': 'thiamine hydrochloride'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-23', 'studyFirstSubmitDate': '2013-05-23', 'studyFirstSubmitQcDate': '2013-05-23', 'lastUpdatePostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'infant thiamine concentration', 'timeFrame': '5 days', 'description': 'infant blood thiamine and thiamine diphosphate concentrations after 5 days of maternal supplementation'}], 'primaryOutcomes': [{'measure': 'blood thiamine concentration', 'timeFrame': '5 days', 'description': 'blood thiamine and thiamine diphosphate concentrations after 5 days of maternal oral thiamine supplementation'}], 'secondaryOutcomes': [{'measure': 'breast milk thiamine concentration', 'timeFrame': '5 days', 'description': 'breast milk thiamine concentration after 5 days of maternal thiamine supplementation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['thiamine deficiency'], 'conditions': ['Beriberi']}, 'referencesModule': {'references': [{'pmid': '22703952', 'type': 'BACKGROUND', 'citation': 'Coats D, Shelton-Dodge K, Ou K, Khun V, Seab S, Sok K, Prou C, Tortorelli S, Moyer TP, Cooper LE, Begley TP, Enders F, Fischer PR, Topazian M. Thiamine deficiency in Cambodian infants with and without beriberi. J Pediatr. 2012 Nov;161(5):843-7. doi: 10.1016/j.jpeds.2012.05.006. Epub 2012 Jun 14.'}, {'pmid': '23864540', 'type': 'DERIVED', 'citation': 'Coats D, Frank EL, Reid JM, Ou K, Chea M, Khin M, Preou C, Enders FT, Fischer PR, Topazian M. Thiamine pharmacokinetics in Cambodian mothers and their breastfed infants. Am J Clin Nutr. 2013 Sep;98(3):839-44. doi: 10.3945/ajcn.113.062737. Epub 2013 Jul 17.'}]}, 'descriptionModule': {'briefSummary': 'Thiamine deficiency causes beriberi and is common in parts of rural Cambodia, where it appears to be a leading cause of infant death. The change in maternal and infant thiamine level after administration of thiamine to either Cambodian mothers or their infants is unknown. Normal human breast milk thiamine levels in thiamine-replete mothers are poorly characterized. The aim of this study is to determine if thiamine administered to nursing Cambodian mothers normalizes maternal and infant thiamine levels. Levels will also be obtained in nursing Caucasian mothers residing in the United States.', 'detailedDescription': "In this pharmacokinetic study, thiamine hydrochloride 100 mg will be administered to nursing Cambodian mothers and thiamine levels will be measured in their blood and breast milk before and after supplementation. Their infant's blood thiamine levels will also be measured. A control arm of American breast feeding mothers taking prenatal vitamins will also be enrolled, to allow comparison of maternal blood and breast milk levels between Cambodian and American mothers. Ethics committee approval was obtained in Cambodia (National Ethics Committee for Health Research #208, 2011) and in the United States (Mayo Clinic Rochester IRB #12-004047)for the Cambodian and American portions of the protocol, respectively."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mother is at least 18 years of age\n* Infant is between 1 and 12 months of age\n* Cambodian infant is exclusively breast fed\n* Cambodian mother has not taken vitamin supplements within the past month\n* American mother has been taking prenatal vitamins throughout pregnancy and postpartum while breastfeeding\n* Mother and infant do not have an acute illness at the time of enrollment\n* Mother and infant are able to comply with study visits\n\nExclusion Criteria:\n\n* Mother is not able to provide informed consent\n* Cambodian infant has received thiamine injections within the past 2 months'}, 'identificationModule': {'nctId': 'NCT01864057', 'briefTitle': 'Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants', 'orgStudyIdInfo': {'id': 'MCR 12-004047; NECHR 208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cambodian mothers', 'description': 'thiamine hydrochloride 100 mg orally daily for 5 days', 'interventionNames': ['Drug: thiamine hydrochloride 100 mg']}, {'type': 'NO_INTERVENTION', 'label': 'American mothers', 'description': 'Baseline blood and breast milk sample collection'}], 'interventions': [{'name': 'thiamine hydrochloride 100 mg', 'type': 'DRUG', 'armGroupLabels': ['Cambodian mothers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'city': 'Mesang District', 'state': 'Prey Veng', 'country': 'Cambodia', 'facility': 'Svai Chrum Clinic'}], 'overallOfficials': [{'name': 'Mark Topazian, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eastern Mennonite Missions', 'class': 'UNKNOWN'}, {'name': 'ARUP Laboratories', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Mark Topazian', 'investigatorAffiliation': 'Mayo Clinic'}}}}