Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants

NCT01864057 | Completed Phase 1

• 1 other identifier: MCR 12-004047; NECHR 208
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 2

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.

Conditions

Beriberi

Keywords

thiamine deficiency

Outcome Measures

Primary Outcomes (1)

• blood thiamine concentration

  blood thiamine and thiamine diphosphate concentrations after 5 days of maternal oral thiamine supplementation

  5 days

Secondary Outcomes (1)

• breast milk thiamine concentration

  5 days

Other Outcomes (1)

• infant thiamine concentration

  5 days

Study Arms (2)

Cambodian mothers

ACTIVE COMPARATOR

thiamine hydrochloride 100 mg orally daily for 5 days

Drug: thiamine hydrochloride 100 mg

American mothers

NO INTERVENTION

Baseline blood and breast milk sample collection

Interventions

thiamine hydrochloride 100 mg DRUG

Cambodian mothers

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Mother is not able to provide informed consent
• Cambodian infant has received thiamine injections within the past 2 months

Sponsors & Collaborators

• Mayo Clinic: lead
• Eastern Mennonite Missions: collaborator
• ARUP Laboratories: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Svai Chrum Clinic

Mesang District, Prey Veng, Cambodia

Location

Related Publications (2)

• 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.

  PMID: 22703952 BACKGROUND

• 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.

  PMID: 23864540 DERIVED

MeSH Terms

Conditions

Beriberi; Thiamine Deficiency

Interventions

thiamine hydrochloride

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Mark Topazian, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: May 29, 2013
• Study Start: January 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

CA (1); US (1)