Trial | NCT01864057  Report issue

Official Title

Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    thiamine ...

  • Study Participants

    24
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.
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 Started
Jan 31
2012
Primary Completion
Jul 31
2012
Study Completion
Sep 30
2012
Last Update
May 29
2013
Estimate

Drug thiamine hydrochloride 100 mg

Cambodian mothers Active Comparator

thiamine hydrochloride 100 mg orally daily for 5 days

American mothers No Intervention

Baseline blood and breast milk sample collection

Criteria 

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
No Results Posted