Clinical trial NCT01864057: Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants
Official title: Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Beriberi
Keywords: thiamine deficiency
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Eastern Mennonite Missions
name: ARUP Laboratories
First posted: 2013-05-29
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: blood thiamine concentration
timeFrame: 5 days
Secondary outcomes:
measure: breast milk thiamine concentration
timeFrame: 5 days
Other outcomes:
measure: infant thiamine concentration
timeFrame: 5 days
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Mesang District
country: Cambodia
facility: Svai Chrum Clinic
state: Prey Veng
Study officials:
affiliation: Mayo Clinic
name: Mark Topazian, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coats D, Shelton-Dodge K, Ou K, Khun V, Seab S, Sok K, Prou C, Tortorelli S, Moyer TP, Cooper LE, Begley TP, Enders F, Fischer PR, Topazian M. Thiamine deficiency in Cambodian infants with and without beriberi. J Pediatr. 2012 Nov;161(5):843-7. doi: 10.1016/j.jpeds.2012.05.006. Epub 2012 Jun 14.
citation: Coats D, Frank EL, Reid JM, Ou K, Chea M, Khin M, Preou C, Enders FT, Fischer PR, Topazian M. Thiamine pharmacokinetics in Cambodian mothers and their breastfed infants. Am J Clin Nutr. 2013 Sep;98(3):839-44. doi: 10.3945/ajcn.113.062737. Epub 2013 Jul 17.