Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants

Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants

Sponsors

Lead Sponsor: Mayo Clinic

Collaborator: Eastern Mennonite Missions
ARUP Laboratories

Source Mayo Clinic
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.

Overall Status Completed
Start Date January 2012
Completion Date September 2012
Primary Completion Date July 2012
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
blood thiamine concentration 5 days
Secondary Outcome
Measure Time Frame
breast milk thiamine concentration 5 days
Enrollment 24
Condition
Intervention

Intervention Type: Drug

Intervention Name: thiamine hydrochloride 100 mg

Arm Group Label: Cambodian mothers

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Mark Topazian, M.D. Principal Investigator Mayo Clinic
Location
Facility:
Mayo Clinic | Rochester, Minnesota, 55905, United States
Svai Chrum Clinic | Mesang District, Prey Veng, Cambodia
Location Countries

Cambodia

United States

Verification Date

May 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Mayo Clinic

Investigator Full Name: Mark Topazian

Investigator Title: PI

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Cambodian mothers

Type: Active Comparator

Description: thiamine hydrochloride 100 mg orally daily for 5 days

Label: American mothers

Type: No Intervention

Description: Baseline blood and breast milk sample collection

Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Basic Science

Masking: None (Open Label)

Source: ClinicalTrials.gov