Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants

May 23, 2013 updated by: Mark Topazian, Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cambodia
    • Prey Veng
      • Mesang District, Prey Veng, Cambodia
        • Svai Chrum Clinic
  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Mother is at least 18 years of age
  • Infant is between 1 and 12 months of age
  • Cambodian infant is exclusively breast fed
  • Cambodian mother has not taken vitamin supplements within the past month
  • American mother has been taking prenatal vitamins throughout pregnancy and postpartum while breastfeeding
  • Mother and infant do not have an acute illness at the time of enrollment
  • Mother and infant are able to comply with study visits

Exclusion Criteria:

  • Mother is not able to provide informed consent
  • Cambodian infant has received thiamine injections within the past 2 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cambodian mothers
thiamine hydrochloride 100 mg orally daily for 5 days
Drug: thiamine hydrochloride 100 mg
No Intervention: American mothers
Baseline blood and breast milk sample collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood thiamine concentration
Time Frame: 5 days
blood thiamine and thiamine diphosphate concentrations after 5 days of maternal oral thiamine supplementation
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
breast milk thiamine concentration
Time Frame: 5 days
breast milk thiamine concentration after 5 days of maternal thiamine supplementation
5 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
infant thiamine concentration
Time Frame: 5 days
infant blood thiamine and thiamine diphosphate concentrations after 5 days of maternal supplementation
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

ARUP Laboratories
Eastern Mennonite Missions

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

May 23, 2013

First Submitted That Met QC Criteria

May 23, 2013

First Posted (Estimate)

May 29, 2013

Study Record Updates

Last Update Posted (Estimate)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 23, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCR 12-004047; NECHR 208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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