drugset / Trial / NCT01864057
Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants
Phase 1
Completed
24 enrolled
Mayo Clinic
ARUP Laboratories · collabEastern Mennonite Missions · collab
Non-randomizedSingle-groupOpen-labelBasic science
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.
Timeline
- Start
- 2012-01
- Primary completion
- 2012-07
- Completion
- 2012-09
Publications
- Background 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Thiamine | Other / unclassified | 100 mg | Oral |