Thiamine Supplement in Patients With Severe Hyperthyroidism
Primary Purpose
Thyrotoxicosis
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Thiamine
Sponsored by
About this trial
This is an interventional treatment trial for Thyrotoxicosis focused on measuring Thiamine, Congestive heart failure, Atrial fibrillation, Graves' disease
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine Ramathibodi Hospital, Mahidol University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Thiamine
No thiamine
Arm Description
Thiamine intravenously 100 mg/day for 3 days
No thiamine was given to the patient
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02767245
Brief Title
Thiamine Supplement in Patients With Severe Hyperthyroidism
Official Title
Efficacy of Thiamine Supplement for Improve Cardiovascular Function in Patients With Severe Hyperthyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ramathibodi Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyrotoxicosis
Keywords
Thiamine, Congestive heart failure, Atrial fibrillation, Graves' disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thiamine
Arm Type
Active Comparator
Arm Description
Thiamine intravenously 100 mg/day for 3 days
Arm Title
No thiamine
Arm Type
No Intervention
Arm Description
No thiamine was given to the patient
Intervention Type
Drug
Intervention Name(s)
Thiamine
Other Intervention Name(s)
vitamin B1
Intervention Description
Thiamine IV 100 mg/day
Primary Outcome Measure Information:
Title
left ventricular systolic function
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chutintorn Sriphrapradang, M.D.
Organizational Affiliation
Ramathibodi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Ramathibodi Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Thiamine Supplement in Patients With Severe Hyperthyroidism
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