NCT04778865Unknown不适用
Effect of Vitamin D Supplementation on Autoimmunity and Thyroid Function in Subjects With Hashimoto's Thyroiditis and Vitamin D Deficiency: Clinical Pilot Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline antithyroid antibodies at 3 months
研究概览
简要总结
The objective of this study is to evaluate the effect of vitamin D supplementation on thyroid autoimmunity, thyroid function, and other metabolic and clinical variables associated with the thyroid axis in patients with Hashimoto's thyroiditis and vitamin D deficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •women between 18-45 years old (pre-menopausal stage)
- •men between 18-60 years old
- •BMI between 18.5-34.9 kg/ m2
- •medical diagnosis of Hashimoto's thyroiditis
- •treatment with levothyroxine (LT4) with stable dose (from four months from the start of the intervention)
- •positive antithyroid antibody (peroxidase and/or thyroglobulin)
- •serum 25 (OH) D levels <20 ng / ml.
排除标准
- •radioiodine, thyroidectomy, antithyroid treatment
- •disease, condition or drug treatment that alters the immune system or hypothalamic-pituitary-thyroid axis or vitamin D metabolism.
- •disorder of kidney, liver, or bone-metabolic function
- •Graves disease, toxic nodular goiter, postpartum thyroiditis, coronary heart disease, epilepsy, cancer, Turner or Down syndrome, primary hyperparathyroidism
- •vitamin D, calcium, complex B, omega-3 supplements
- •pregnant or breastfeeding
- •type 2 diabetes or dyslipidemia with drug treatment at unstable doses
- •intense physical activity
研究组 & 干预措施
Vitamin D-correction
Experimental
Subjects will receive one capsule with 50.000 IU cholecalciferol weekly for 3 months.
干预措施: Vitamin D-correction (Dietary Supplement)
Vitamin D-RDA
Active Comparator
Subjects will receive one capsule with 4.200 IU cholecalciferol weekly for 3 months.
干预措施: Vitamin D-RDA (Dietary Supplement)
结局指标
主要结局
Change from baseline antithyroid antibodies at 3 months
时间窗: Basal and final (after 3 months)
Anti-thyroid peroxidase and anti-thyroglobulin antibodies (UI/mL)
次要结局
- Change from baseline Thyroid stimulating hormone at 3 months(Basal and final (after 3 months))
- Change from baseline Free thyroxine at 3 months(Basal and final (after 3 months))
- Change from baseline Total triiodothyronine at 3 months(Basal and final (after 3 months))
- Change from baseline Lipid profile at 3 months(Basal and final (after 3 months))
- Change from baseline glycemia at 3 months(Basal and final (after 3 months))
- Change from baseline ThyPro-39 at 3 months(Basal and final (after 3 months))
- Change from baseline SF-36 at 3 months(Basal and final (after 3 months))
研究者
Claudia Vega Soto
Nutritionist
Universidad de Valparaiso
研究点 (1)
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