Clinical Trial: Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants

Brief 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.

Detailed Summary: 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.
Sponsor: Mayo Clinic

Current Primary Outcome: blood thiamine concentration [ Time Frame: 5 days ]

blood thiamine and thiamine diphosphate concentrations after 5 days of maternal oral thiamine supplementation


Original Primary Outcome: Same as current

Current Secondary Outcome: breast milk thiamine concentration [ Time Frame: 5 days ]

breast milk thiamine concentration after 5 days of maternal thiamine supplementation


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: May 23, 2013
Date Started: January 2012
Date Completion:
Last Updated: May 23, 2013
Last Verified: May 2013