Beriberi
Conditions
Keywords
thiamine deficiency
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 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 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.
Interventions
Sponsors
Eastern Mennonite Missions
ARUP Laboratories
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood thiamine concentration | 5 days | blood thiamine and thiamine diphosphate concentrations after 5 days of maternal oral thiamine supplementation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| breast milk thiamine concentration | 5 days | breast milk thiamine concentration after 5 days of maternal thiamine supplementation |
Other
| Measure | Time frame | Description |
|---|---|---|
| infant thiamine concentration | 5 days | infant blood thiamine and thiamine diphosphate concentrations after 5 days of maternal supplementation |
Countries
Cambodia, United States
Outcome results
None listed