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Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants

NCT01864057 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-05-29

No results posted yet for this study

Summary

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.

Conditions

  • Beriberi

Interventions

DRUG

thiamine hydrochloride 100 mg

Sponsors & Collaborators

  • Eastern Mennonite Missions

    collaborator UNKNOWN

  • ARUP Laboratories

    collaborator OTHER

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Mark Topazian, M.D. · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-07-31
Completion
2012-09-30

Countries

  • United States
  • Cambodia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01864057 on ClinicalTrials.gov