- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02767245
Thiamine Supplement in Patients With Severe Hyperthyroidism
Efficacy of Thiamine Supplement for Improve Cardiovascular Function in Patients With Severe Hyperthyroidism
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bangkok, Thailand, 10400
- Faculty of Medicine Ramathibodi Hospital, Mahidol University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Exclusion Criteria:
- Previously treated with thiamine within 1 month before the enrollment
- End-stage renal disease
- Alcoholism
- Pregnant or lactating women
- Post gastric bypass surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Thiamine
Thiamine intravenously 100 mg/day for 3 days
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Thiamine IV 100 mg/day
Other Names:
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No Intervention: No thiamine
No thiamine was given to the patient
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
left ventricular systolic function
Time Frame: 3 months
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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.
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3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chutintorn Sriphrapradang, M.D., Ramathibodi Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-56-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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