Hemostatic effects of levothyroxine and selenomethionine in euthyroid women with Hashimoto's thyroiditis
Hemostatic effects of levothyroxine and selenomethionine in euthyroid women with Hashimoto's thyroiditis: a six-month single-center, randomized, double-blind, placebo-controlled study
the Polish Committee of Scientific Research
155 participants
May 31, 2005
Interventional
Conditions
Summary
The aim of this study was to investigate the effects of levothyroxine and selenomethionine, administered alone or in combination, on hemostatic risk factors in Hashimoto’s thyroiditis patients with normal thyroid function tests. The study involved a group of 155 euthyroid women with recently diagnosed and previously untreated Hashimoto’s thyroiditis allocated into one of the following treatment options: levothyroxine, selenomethionine, levothyroxine and selenomethionine, or placebo. Levothyroxine was administered at the daily dose of 0.5 microg/kg for patients with TSH levels below 1.0 mIU/mL, 0.75 microg/kg for individuals with TSH levels between 1.0 and 2.0 mIU/mL, and 1 microg/kg for patients with a TSH above 2.0 mIU/mL. In turn, the dose of selenomethionine (200 microg daily) was independent of plasma TSH levels. Taking history, clinical examination and venous blood sampling for evaluating safety laboratory parameters were performed every 2 weeks. Compliance was assessed by pill counts during each visit and will be considered satisfactory when the number of tablets taken by a patient is ranged from 90% to 110% Laboratory assays were be performed three times: before treatment and after three and six months of levothyroxine and/or selenomethionine. We measured the international normalized ratio, the partial thromboplastin time, plasma levels/activities of fibrinogen, von Willebrand factor , factor VII, factor X and plasminogen activator inhibitor-1.
Eligibility
Inclusion Criteria1
- (a) positive antibodies (>100 U/mL) against thyroid peroxidase (TPOAb), (b) the reduced echogenicity of the thyroid parenchyma on thyroid ultrasonography, (c) serum TSH less than 4.0 mU/L, and (d) plasma levels of free thyroxine (fT4) and free triiodothyronine (fT3)) within the reference range
Exclusion Criteria15
- A) any acute and chronic inflammatory processes
- B) other autoimmune disorders
- C) positive serum antibodies against TSH receptor
- D) current treatment with thyroid hormones
- E) concomitant treatment with drugs that may affect inflammatory processes in the vascular wall
- F) concomitant treatment with other drugs known either to affect thyroid hormones or to interact with levothyroxine and selenomethionine
- G) BMI>40 kg/m2
- H) Turner or Down syndrome
- I) any form of coronary artery disease
- J) moderate or severe arterial hypertension (ESC/ESH grade 2 or 3)
- K) symptomatic congestive heart failure
- L) diabetes, impaired glucose tolerance or impaired fasting glucose
- M) impaired renal or hepatic function
- N) pregnancy or lactation
- O) poor patient compliance
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The included Hashimoto’s thyroiditis patients were randomized in a double-blind manner to receive oral capsules of levothyroxine sodium (n=39) (arm 1), selenomethionine (n=39) (arm 2), levothyroxine sodium + selenomethionine (n=40) (arm 3), or of placebo (n=37) (arm 4) for six months. Levothyroxine was administered at the daily dose of 0.5 microg/kg for patients with TSH levels below 1.0 mIU/mL, 0.75 microg/kg for individuals with TSH levels between 1.0 and 2.0 mIU/mL, and 1 microg/kg for patients with a TSH above 2.0 mIU/mL. In turn, the dose of selenomethionine (200 microg daily) was independent of plasma TSH levels. This study was in part a sub-study of another trial (ACTRN12611000238976), which assessed the effect of levothyroxine and selenomethionine, administered alone or in combination, on monocyte and lymphocyte cytokine release. The randomization procedure as well as treatment regimen in this study were the same as in ACTRN12611000238976 trial. Nineteen patients in arm 1, 20 patients in arm 2, 18 patients in arm 3, 16 patients in arm 4 and 18 healthy women simultaneously participated in in ACTRN12611000238976 trial, while the remaining ones only in this study. Because participation in both studies required collection of more blood sample volume, the participants were included in both studies only if they agreed on it. If not, they were included only in one of the two studies (using central randomization by computer). The total duration of treatment: 6 months.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12612000271808