Status:
COMPLETED
Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Eastern Mennonite Missions
ARUP Laboratories
Conditions:
Beriberi
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 administrat...
Detailed Description
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 supp...
Eligibility Criteria
Inclusion
- 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
- Mother is not able to provide informed consent
- Cambodian infant has received thiamine injections within the past 2 months
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01864057
Start Date
January 1 2012
End Date
September 1 2012
Last Update
May 29 2013
Active Locations (2)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
Svai Chrum Clinic
Mesang District, Prey Veng, Cambodia