Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Beriberi

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cambodian mothers

thiamine hydrochloride 100 mg orally daily for 5 days

Group Type ACTIVE_COMPARATOR

thiamine hydrochloride 100 mg

Intervention Type DRUG

American mothers

Baseline blood and breast milk sample collection

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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thiamine hydrochloride 100 mg

Intervention Type DRUG

Eligibility Criteria

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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