Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants

Beriberi Clinical Trial

Official title:

Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864057
• Other study ID #: MCR 12-004047; NECHR 208
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2013
• Last updated: May 23, 2013
• Start date: January 2012
• Est. completion date: September 2012

Study information

• Verified date: May 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cambodia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Beriberi

Intervention

Drug:
• thiamine hydrochloride 100 mg

Locations

Country	Name	City	State
Cambodia	Svai Chrum Clinic	Mesang District	Prey Veng
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	ARUP Laboratories, Eastern Mennonite Missions

Countries where clinical trial is conducted

United States,  Cambodia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	infant thiamine concentration	infant blood thiamine and thiamine diphosphate concentrations after 5 days of maternal supplementation	5 days	No
Primary	blood thiamine concentration	blood thiamine and thiamine diphosphate concentrations after 5 days of maternal oral thiamine supplementation	5 days	No
Secondary	breast milk thiamine concentration	breast milk thiamine concentration after 5 days of maternal thiamine supplementation	5 days	No