CompletedPhase 4ACTRN12611000238976

The effect of levothyroxine and selenomethionine on lymphocyte and monocyte cytokine release in women with Hashimoto’s thyroiditis

The effect of levothyroxine and selenomethionine on lymphocyte and monocyte cytokine release in women with Hashimoto’s thyroiditis: a six-month single-center, randomized, double-blind, placebo-controlled study


Sponsor

the Polish Committee of Scientific Research

Enrollment

211 participants

Start Date

May 15, 2005

Study Type

Interventional

Conditions

Summary

The aim of the study was to compare the effect of levothyroxine and selenomethionine on monocyte and lymphocyte cytokine release and systemic inflammation in patients with Hashimoto’s thyroiditis. The study was a six-month single-center, randomized, double-blind, placebo-controlled study. The included patients with Hashimoto’s thyroiditis were randomized in a double-blind manner to receive levothyroxine sodium (n=42), selenomethionine (n=43), levothyroxine sodium + selenomethionine (n=43), or placebo (n=42). Levothyroxine was administered at the daily dose of 0.5 µg/kg for patients with TSH levels below 1.0 mIU/mL, 0.75 µg/kg for individuals with TSH levels between 1.0 and 2.0 mIU/mL, and 1 µg/kg for patients with a TSH above 2.0 mIU/mL. In turn, the dose of selenomethionine (200 µg 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 for first two months and then every 4 weeks thereafter. Compliance was be 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 performed three times: before treatment and after three and six months of levothyroxine and/or selenomethionine administration..We determined plasma levels of TSH, free thyroxine and free triiodothyronine, plasma thyroid peroxidase and thyroglobulin antibodies, lipid profile, plasma glucose and insulin and plasma high sensitivity C-reactive protein levels (hsCRP), as well as monocyte release of tumor necrosis factor-alpha (TNF-alpha), interleukin-1beta, interleukin-6 and monocyte chemoattractant protein-1 (MCP-1), and lymphocyte release of TNF-alpha, interleukin-2, interferon-gamma.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether treatment with thyroid hormone (levothyroxine) and selenium supplements can improve immune function in women with Hashimoto's thyroiditis, an autoimmune condition affecting the thyroid gland. It is for women aged 18 to 60 who have confirmed Hashimoto's with high thyroid antibodies but currently normal thyroid function.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The included Hashimoto’s thyroiditis patients were randomized in a double-blind manner to receive oral capsules of levothyroxine sodium (n=42) (arm 1), selenomethionine (n=43) (arm 2), levothyroxine s

The included Hashimoto’s thyroiditis patients were randomized in a double-blind manner to receive oral capsules of levothyroxine sodium (n=42) (arm 1), selenomethionine (n=43) (arm 2), levothyroxine sodium + selenomethionine (n=43) (arm 3), or of placebo (n=42) (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. The total duration of treatment: 6 months, the total duration of follow-up: 12 months


Locations(1)

Poland

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ACTRN12611000238976