Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants

Study Overview
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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.

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.

Official Title
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Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants

Conditions
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Beriberi

Intervention / Treatment
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* Drug: thiamine hydrochloride 100 mg


Participation Criteria
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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 Exclusion Criteria: Mother is not able to provide informed consent Cambodian infant has received thiamine injections within the past 2 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood thiamine concentration | 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 | breast milk thiamine concentration after 5 days of maternal thiamine supplementation | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thiamine deficiency