NCT02393183撤回2 期
The Effect of a New Antioxidant Combination (ASTED) on Mild Thyroid Eye Disease, a Placebo Controlled Randomized Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change of total eye score (NOSPECS severity score)
研究概览
简要总结
This randomized clinical trial is designed to evaluate the effect of selected antioxidant vitamins and minerals supplement named as ASTED:
- β- Carotene (30 mg)
- Vit C (100 mg)
- Vit E (Alpha-Tocopherol Acetate): 60-200 IU
- Calcium phosphate dihydrate (40 mg)
- Zinc oxide (4 mg, elemental)
- Copper gluconate (3.5 mg)
- Sodium selenite 23 mg= Selenium 100 µg
- Nicotinamide (a form of vit.B3) (10 mg)
in patients with mild Thyroid eye disease according to EUGOGO classification. To be given twice a day.
详细描述
- To determine total eye score (NOSPECS severity score) before and after treatment in each of the three arms of the study and make a before - after as well as an inter-arm comparison.
- To determine Score of thyroid eye disease Quality of life questionnaire (TED-QOL) before and after treatment in each of the three arms of the study and make a before - after as well as an inter-arm comparison.
- To determine clinical activity score (CAS Score) before and after treatment in each of the three arms of the study and make a before - after as well as an inter-arm comparison.
- To determine Serum thyroid auto-antibodies (Anti thyroid peroxidase (TPO), Anti-thyrogluboline) and Thyroid function test (Free T4, T3, and TSH) level before and after treatment in each of the three arms of the study and make a before - after as well as an inter-arm comparison.
- To determine the rate of side effects in each arm and make a comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild TED of less than 18 months duration (as recorded by the patient).
- •No active state (Clinical activity score of less than 3).
- •No previous specific therapy for TED, except for local measures (artificial tear, head elevation, low salt diet).
- •Euthyroidism as a result of remission after a course of antithyroid drug (ATD) therapy, or euthyroidism for at least 2 months since commencing ATD or after thyroidectomy, or euthyroidism for at least 6 months after radioiodine therapy. Hypothyroid patients after thyroidectomy or radioiodine were replaced with levothyroxine. Euthyroidism was defined as normal serum free thyroxine, total or free triiodothyronine concentrations, and thyrotropin (TSH) levels below 4 mU/Liter Patients were kept euthyroid for the whole duration of the study.
- •Age 18-70 years.
排除标准
- •TED severity of more than mild TED.
- •Drug and/or alcohol abuse
- •Severe concomitant illness
- •Inability to comply with the study protocol
- •No informed consent
- •Use of selenium- or vitamin/minerals-containing preparations in the last 3 months.
- •Developing more severe TED in the course of the trial so that requires steroid treatment.
研究组 & 干预措施
ASTED
Experimental
Antioxidant Supplements for TED (ASTED):
to evaluate the effect of selected antioxidant vitamins and minerals supplement (Twice daily)
- β- Carotene (30 mg)
- Vit C (100 mg)
- Vit E (Alpha-Tocopherol Acetate): 60-200 IU
- Calcium phosphate dihydrate (40 mg)
- Zinc oxide (4 mg, elemental)
- Copper gluconate (3.5 mg)
- Sodium selenite 23 mg= Selenium 100 µg
- Nicotinamide (a form of vit.B3) (10 mg)
干预措施: ASTED (Drug)
Selenium
Active Comparator
Selenium (100mic) Twice daily
干预措施: Selenium (Dietary Supplement)
Placebo
Placebo Comparator
Placebo Twice daily
干预措施: Placebo (Other)
结局指标
主要结局
Change of total eye score (NOSPECS severity score)
时间窗: 0, 3, 6 months
Change of eye score during the study period
次要结局
- Change of score of thyroid eye disease Quality of life questionnaire (TED-QOL)(0, 3, 6 months)
研究者
研究点 (1)
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