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临床试验/ACTRN12611000238976
ACTRN12611000238976已完成4 期

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

the Polish Committee of Scientific Research0 个研究点目标入组 211 人开始时间: 2011年3月4日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
211

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 60 Years(—)
性别
Female

入选标准

  • Hashimoto's thyroiditis patients:
  • A) females between the ages of 18 and 60 years
  • B) positive antibodies (>100 U/mL) against thyroid peroxidase
  • C) the reduced echogenicity of the thyroid parenchyma on thyroid ultrasonography
  • D) euthyroid function (TSH < 4.0 mU/L, normal values for free thyroxine and free triiodothyronine)
  • Control Group II:
  • age-, weight-, blood pressure-, and lipid-profile-matched healthy women
  • Participants were medically stable, and, in the judgment of the investigators, otherwise acceptable for entry on the basis of the findings of medical history, physical examination, and routine laboratory tests

排除标准

  • 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

研究者

发起方
the Polish Committee of Scientific Research

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