Selenium Supplementation Treatment in Euthyroid Pregnant Women With Autoimmune Thyroid Disease: Effects on Obstetrical Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 22
- 主要终点
- Changes in TPOab and/or Tgab
研究概览
简要总结
Serum levels of isolated anti-thyroperoxidase (TPOab) and anti-thyreoglobulin (Tgab) autoantibodies are strongly associated with an increased risk of miscarriage and premature deliveries in euthyroid pregnant women. Replacement of thyroxine (LT4) or other supplementations in euthyroid-Ab positivity during pregnancy has not been established. The development of a safe and effective intervention that modulates inappropriate inflammatory responses could be a very important component of prevention against adverse health outcomes during pregnancy.
The anti-oxidant Selenium (Se) suppresses autoimmune destruction of thyrocytes and at daily dose of 200 mcg and 100 mcg decreases titers of serum TPOAb and TgAb also in Se-non-deficient patients with autoimmune thyroiditis (AIT).
The use of Se in AIT has been shown to reduce the incidence of postpartum thyroiditis and hypothyroidism.
Women with recurrent pregnancy loss had lower Se levels and Se deficiency has been implicated in the pathogenesis of AIT and in the impairment of T/B cell-mediated immunity.
The purpose of the present study is performed to establish the effect of Se supplementation in euthyroid women with AIT (pregnant and in whom embryo transfer is expected within 60 days) on Ab trend, thyroid function and structure, implantation rates, pregnancy rates, pregnancy outcome and number of obstetrical, fetal and neonatal complications.
详细描述
Adverse outcomes, postpartum thyroid dysfunction and permanent hypothyroidism have been associated with isolated TPOab positivity in euthyroid pregnant women.
In areas with severe selenium deficiency there is a higher incidence of thyroiditis due to a decreased activity of selenium-dependent glutathione peroxidase activity within thyroid cells. Selenium-dependent enzymes also have several modifying effects on the immune system. Therefore, even mild selenium deficiency may contribute to the development and maintenance of autoimmune thyroid diseases.
Selenium substitution exerts anti-inflammatory and anti-oxidant activities. Se could represents an important supplementation in euthyroid women with AIT in order to improve thyroid function and structure and to prevent obstetrical adverse events related to autoimmune diseases and reactive oxygen species, such as recurrent miscarriage and pre-eclampsia.
The aim of this study is to document the effects of Selenium Supplementation with and without L-thyroxine (LT4) in euthyroid women with AIT, during pregnancy.
This protocol will evaluate the trend of TPOab and Tgab, selenium concentration, thyroid volume and echogenicity, nodule formation and number of adverse effects that affect the mother (during and after pregnancy), the fetus, the infant and the heath service, needing to elucidate the nature of the emerging associations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women with 10°± 2 weeks of gestation
- •women in whom embryo transfer is expected within 60 days
- •euthyroid women (0.4 μIU/ml < TSH < 2.5 μIU/ml), positive for TPOab and/or TgAb, not assuming LT4 replacement
- •euthyroid women (0.4 μIU/ml < TSH < 2.5 μIU/ml), positive for TPOab and/or TgAb under LT4 replacement (to maintain TSH within the control range).
- •women with TSH > 2.5 μIU/ml positive for TPOab and/or TgAb, not assuming LT4 replacement (requiring the beginning of LT4 replacement)
- •women with TSH > 2.5 μIU/ml positive for TPOab and/or TgAb, under LT4 replacement (requiring an adjustment of LT4 replacement)
排除标准
- •use of dietary supplements containing selenium in the previous 4 months;
- •use of antidepressive/psychotic drugs, amiodarone, propanolol, lithium, cytokines;
- •history of hyperthyroidism positive anti-thyrotropin ab;
- •previous partial or total thyroidectomy;
- •known fetal anomaly;
- •known infections (PID, HIV, HCV) and mola hydatidoses;
- •chronic renal failure;
- •uncontrolled hypertension;
- •uterine malformation;
- •history of medical and metabolic complication such as heart disease or diabetes;
- •previous embryo transfer failed within last 3 months;
- •miscarriage within last 3 months;
- •gestational diabetes in previous pregnancies.
研究组 & 干预措施
Sugar Pill Placebo
干预措施: Sugar Pill Placebo (Other)
Selenium + L-Thyroxine (LT4)
干预措施: Selenium + L-Thyroxine (LT4) (Other)
Sugar Pill Placebo + L-Thyroxine (LT4)
干预措施: Sugar Pill Placebo + L-Thyroxine (LT4) (Other)
Selenium
干预措施: Selenium (Dietary Supplement)
结局指标
主要结局
Changes in TPOab and/or Tgab
时间窗: 0 and 14 ± 2, 24 ± 2, 32± 2, 36± 2 weeks; and between 3° and 6° month after labour; and optionally 12° after labour
TPOab and Tgab titers will be measured using a ECLIA kit. Plasma selenium concentration will also be measured
次要结局
- Changes in thyroid hormones (TSH, FT4, FT3)(0 and 14 ± 2, 24 ± 2, 32± 2, 36± 2 weeks; and between 3° and 6° month after labour; and optionally 12° after labour)
- Evaluation of Infant risks(From the date of labour until the date of the first documented event)
- Changes in of quality of life(0 and 14 ± 2, 24 ± 2, 32± 2, 36± 2 weeks; and between 3° and 6° month after labour; and optionally 12° after labour)
- Changes in implantation and pregnancy rates(From the date of embryo transfer until the date of documented progression)
- Changes in thyroid volume and echogenicity(0 and 14 ± 2, 24 ± 2, 32± 2, 36± 2 weeks; and between 3° and 6° month after labour; and optionally 12° after labour)
- Evaluation of Maternal risks(From the date of randomization until the date of first documented event)
- Changes in the selenium-dependent antioxidant enzyme glutathione peroxidase(0, 24 ± 2, 36± 2 weeks; and 6 months after labour)
- Evaluation of Health Services:(from the date of admission until the date of discharge)
研究者
Andrea M. Isidori
Principal Investigator, Clinical Professor
University of Roma La Sapienza