An interventional study of Thiamine in Thyrotoxicosis, sponsored by Ramathibodi Hospital. Completed at 1 site in Thailand. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2016-10-04.
Sponsored by Ramathibodi Hospital · Not applicable, Interventional, and Treatment
Thyrotoxicosis is a hypermetabolic state in which there is increased utilization of thiamine. Thiamine deficiency has been observed in association with hyperthyroidism. Several studies documented that thiamine treatment could improve signs and symptoms of congestive heart failure, or even improve left ventricular ejection fraction in patients without thyrotoxicosis. This pilot study aims to evaluate prevalence of thiamine deficiency and assess improvement of cardiovascular function after receiving thiamine supplement in thyrotoxic patients.
The prevalence of thiamine or vitamin B1 deficiency has been documented in 21-98% of patients with heart failure. Thiamine has multiple effects on the cardiovascular system. It has important hemodynamic effects on the circulatory system as well as direct positive pharmacologic effects on the heart. Thiamine deficiency has been shown to cause cardiac hypertrophy, depressed cardiac contractility, and dysrhythmias. Thiamine is of particular interest in the management of heart failure for several reasons. Heart failure is a disease of the elderly whose micronutrient status is in need of attention. Heart failure patients tend to have inadequate nutrient intake, which has been associated with thiamine deficiency. Use of loop diuretic is associated with the loss of water-soluble vitamins, including thiamine. Several studies have examined the role of thiamine supplementation in patients with heart failure. Clinical trials in patients with congestive heart failure have shown that thiamine supplementation increases the systolic, diastolic, and central venous pressures, with a decline in heart rate and increase in left ventricular ejection fraction (LVEF). Thiamine acts as a vasodilator and reduces the afterload on the heart, thus improving cardiac function. Thiamine has also been reported to increase diuresis and natriuresis in patients with heart failure receiving diuretics.
Thyrotoxicosis considerably increases the demand for thiamine. In vivo study in a rat model demonstrated that thyroid hormones have a direct influence on mitochondria which is the main source of energy. Thiamine in its various forms functions as an important coenzyme for macronutrient oxidation and the production of adenosine triphosphate. Thiamine pyrophosphate works in several oxidative decarboxylation reactions and is a catalyst in the reactions of Krebs cycle. Therefore, thiamine seems to decrease in the case of an increased tissue metabolism. In the previous case reports, they described the possible association between thyrotoxicosis and thiamine deficiency in patients manifested as Wernicke-Korsakoff syndrome.
Despite lack of the evidence of benefit of thiamine therapy in patients with severe thyrotoxicosis or thyroid storm, some experts recommended thiamine in conjunction with other supportive treatment. We aimed to investigate the effect of thiamine on cardiac function in patients with severe thyrotoxicosis in a prospective, randomized, open, blinded end-point study using echocardiographic as well as clinical endpoints.
111 studies on the registry are indexed under Hyperthyroidism; 28 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 54 interventional studies indexed under Hyperthyroidism.
Browse Hyperthyroidism studies →Ramathibodi Hospital is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Thiamine intravenously 100 mg/day for 3 days
Drug: Thiamine
No thiamine was given to the patient
Thiamine IV 100 mg/day
Also known as: vitamin B1
left ventricular systolic function
Left ventricular systolic function was assessed by using transthoracic 2-dimension echocardiography. The measurement was followed the standard protocol of American Society of Echocardiography including wall thickness, left ventricular size and mass and left ventricular ejection fraction.
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ramathibodi Hospital