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CompletedNCT02767245Updated Oct 4, 2016

Thiamine Supplement in Patients With Severe Hyperthyroidism

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

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Thyrotoxicosis

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Keywords

  • Thiamine
  • Congestive heart failure
  • Atrial fibrillation
  • Graves' disease
03

In context

Hyperthyroidism

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Active comparator
    Thiamine

    Thiamine intravenously 100 mg/day for 3 days

    Drug: Thiamine

  • No intervention
    No thiamine

    No thiamine was given to the patient

Interventions

  • DrugThiamine

    Thiamine IV 100 mg/day

    Also known as: vitamin B1

06

What researchers measure

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.

    Time frame: 3 months

07

Study locations

1 site
  • Faculty of Medicine Ramathibodi Hospital, Mahidol University
    Bangkok, 10400, Thailand
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02767245
Lead sponsor
Ramathibodi Hospital
Responsible party
Chutintorn Sriphrapradang (Assistant Professor, Ramathibodi Hospital) — Principal investigator
First posted
May 10, 2016
Start date
Jan 2014
Primary completion
Jul 2016
Completion
Jul 2016
Last update
Oct 4, 2016

Study contacts

Chutintorn Sriphrapradang, M.D.
principal investigator · Ramathibodi Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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