Abstract

BackgroundHigh dose oral thiamine may have a role in treating diabetes, heart failure, and hypermetabolic states. The purpose of this study was to determine the pharmacokinetic profile of oral thiamine hydrochloride at 100 mg, 500 mg and 1500 mg doses in healthy subjects.MethodsThis was a randomized, double-blind, single-dose, 4-way crossover study. Pharmacokinetic measures were calculated.ResultsThe AUC0-10 hr and Cmax values increased nonlinearly between100 mg and 1500 mg. The slope of the AUC0-10 hr vs dose, as well as the Cmax vs dose, plots are steepest at the lowest thiamine doses.ConclusionOur study demonstrates that high blood levels of thiamine can be achieved rapidly with oral thiamine hydrochloride. Thiamine is absorbed by both an active and nonsaturable passive process.Trial RegistrationClinicalTrials.gov: NCT00981877

Highlights

  • High dose oral thiamine may have a role in treating diabetes, heart failure, and hypermetabolic states

  • Thiamine requirements are related to energy metabolism; 0.33 mg of thiamine are required for every 4400 kJ of energy

  • thiamine diphosphate (ThDP) is a necessary cofactor for enzymes related to carbohydrate metabolism: pyruvate dehydrogenase (PDH), a-ketoglutarate dehydrogenase, and transketolase

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Summary

Introduction

High dose oral thiamine may have a role in treating diabetes, heart failure, and hypermetabolic states. The purpose of this study was to determine the pharmacokinetic profile of oral thiamine hydrochloride at 100 mg, 500 mg and 1500 mg doses in healthy subjects. Vitamin B1, was isolated in 1926 and synthesized in 1936. Its importance for preventing illness was known as early as the turn of the century. Thiamine requirements are related to energy metabolism; 0.33 mg of thiamine are required for every 4400 kJ of energy. For adults the DRI of thiamine is between 1.1 and 1.4 mg per day. The primary active form of the vitamin, thiamine diphosphate (ThDP), is known as thiamine pyrophosphate (TPP). ThDP is a necessary cofactor for enzymes related to carbohydrate metabolism: pyruvate dehydrogenase (PDH), a-ketoglutarate dehydrogenase, and transketolase

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