Thiamine Supplement in Patients With Severe Hyperthyroidism

Sponsor

Ramathibodi Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02767245

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Thyrotoxicosis	Drug: Thiamine	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Thiamine Supplement for Improve Cardiovascular Function in Patients With Severe Hyperthyroidism

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Thiamine Thiamine intravenously 100 mg/day for 3 days	Drug: Thiamine Thiamine IV 100 mg/day Other Names: vitamin B1
No Intervention: No thiamine No thiamine was given to the patient

Arm

Intervention/Treatment

Active Comparator: Thiamine

Thiamine intravenously 100 mg/day for 3 days

Drug: Thiamine

Thiamine IV 100 mg/day

Other Names:

vitamin B1

No Intervention: No thiamine

No thiamine was given to the patient

Outcome Measures

Primary Outcome Measures

left ventricular systolic function [3 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Hospitalized patients with severe thyrotoxicosis
Thyrotoxic patients with cardiovascular involvement e.g. heart rate > 90/min, atrial fibrillation or congestive heart failure
Agree to participate by written informed consent