Thiamine Supplement in Patients With Severe Hyperthyroidism

NCT02767245 | Completed

• 1 other identifier: 10-56-10
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyrotoxicosis

Keywords

Thiamine; Congestive heart failure; Atrial fibrillation; Graves' disease

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (2)

Thiamine

ACTIVE COMPARATOR

Thiamine intravenously 100 mg/day for 3 days

Drug: Thiamine

No thiamine

NO INTERVENTION

No thiamine was given to the patient

Interventions

Thiamine DRUG

Thiamine IV 100 mg/day

Also known as: vitamin B1

Thiamine

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previously treated with thiamine within 1 month before the enrollment
• End-stage renal disease
• Alcoholism
• Pregnant or lactating women
• Post gastric bypass surgery

Sponsors & Collaborators

• Ramathibodi Hospital: lead

Study Sites (1)

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Thyrotoxicosis; Heart Failure; Atrial Fibrillation; Graves Disease

Interventions

Thiamine

Condition Hierarchy (Ancestors)

Hyperthyroidism; Thyroid Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Chutintorn Sriphrapradang, M.D.

  Ramathibodi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 10, 2016
• Study Start: January 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 4, 2016

Record last verified: 2016-10

Locations

TH (1)