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| Name | Class |
|---|---|
| Eastern Mennonite Missions | UNKNOWN |
| ARUP Laboratories | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cambodian mothers | Active Comparator | thiamine hydrochloride 100 mg orally daily for 5 days |
|
| American mothers | No Intervention | Baseline blood and breast milk sample collection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thiamine hydrochloride 100 mg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| blood thiamine concentration | blood thiamine and thiamine diphosphate concentrations after 5 days of maternal oral thiamine supplementation | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| breast milk thiamine concentration | breast milk thiamine concentration after 5 days of maternal thiamine supplementation | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| infant thiamine concentration | infant blood thiamine and thiamine diphosphate concentrations after 5 days of maternal supplementation | 5 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Topazian, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States | ||
| Svai Chrum Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22703952 | 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. | |
| 23864540 | Derived |
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| ID | Term |
|---|---|
| D001602 | Beriberi |
| D013832 | Thiamine Deficiency |
| ID | Term |
|---|---|
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
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| ID | Term |
|---|---|
| C000712172 | thiamine hydrochloride |
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| Mesang District |
| Prey Veng |
| Cambodia |
| 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. |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |