Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Collaborators: ARUP Laboratories; Eastern Mennonite Missions
• Treatments: Thiamine

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