The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease, a Double Blind Placebo Controlled Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Mean of total eye score changes (using NOSPECS severity score)
研究概览
简要总结
ASTED (Antioxidant Supplements for TED) trial is an investigator-initiated, randomized, triple masked, clinical trial of a selected combination of vitamins and minerals versus placebo in patients with moderate to severe thyroid eye disease. The trial has a parallel-arm design.
详细描述
Primary aim: To investigate if ASTED or as compared with placebo could affect the course of TED either by enhancing improvement or preventing worsening in patients with Moderate to severe TED thyroid eye disease (TED) based on:
- Total eye score (NOSPECS severity score) 1 Total eye score is used to assess the severity of TED, which was calculated by multiplying each class of the NOSPECS system1 (except class 0) to its grade of severity (0-3), yielding a maximum total score of 63 and a minimum total score of 0 (the higher the number the worse the severity) The overall ophthalmic outcome is a composite score based on multiple items (Soft tissue, retraction, proptosis, diplopia, and corneal involvement); the use of a composite score circumvents the problem arising from the presence of improvement in one item and simultaneous worsening in another item.
The severity score in each of the classes 1, 2, 3, and 4 will also be separately compared to evaluate the effect of different treatments on each sign. 2. Score of thyroid eye disease Quality of life questionnaire (TED-QOL) 2.
Secondary outcomes measures:
To compare possible change in:
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
- •Moderate to severe TED of less than 18 months duration:
- •Active state (Clinical activity score of 3 and more).
- •No steroid and or any supplement treatment for the last 6 months.
- •Euthyroidism
- •Age 18-70 years.
排除标准
- •Sight-threatening TED
- •Pregnancy
- •Drug and/or alcohol abuse
- •Severe concomitant illness
- •Inability to comply with the study protocol
- •No informed consent
- •Developing more severe TED (Sight threatening TED) in the course of the trial.
- •Contraindications of steroid treatment.
研究组 & 干预措施
Methylprednisolone + ASTED
ASTED (Antioxidant Supplements for Thyroid Eye Disease) includes : B-Carotene (6 mg)+ Vit.C (200 mg) + Vit.E (200 mg) + Nicotinamide(20mg) + Selenium(200mic.) + Zinc oxide (8 mg) + Copper gluconate or oxide (1mg) + Manganese chloride (1.8 mg), Twice a day for 6 months
Methylprednisolone includes :
Methylprednisolone tablet of 50 and 5 mg, company....) 1mg/kg for the first 2 weeks, 0.8mg/kg for 2 weeks, 0.7 mg/kg for 2 weeks, and then tapering off the methylprednisolone in 6 weeks (total duration of 12 weeks) by 8-10 mg per week. For example, a patient with 75 kg weight will receive 75 mg for 2 weeks, 60 mg for 2 weeks, 52.5 mg for 2 weeks, and then decreasing by 8-10 mg per week for 6 weeks. The dose regiment will be written and handed to the patient on the first visit and will be monitored during the follow up.
干预措施: Methylprednisolone + ASTED (Drug)
Methylprednisolone + Placebo
Placebo Twice a day for 6 months Methylprednisolone prescribes as the same as arm 1
干预措施: Methylprednisolone +Placebo (Drug)
结局指标
主要结局
Mean of total eye score changes (using NOSPECS severity score)
时间窗: baseline, 1 month, 3 months, 6 months
Total eye score change during study
Mean of "thyroid eye disease Quality of life" score changes (Using TED-QOL)
时间窗: baseline, 1 month, 3 months, 6 months
Changing quality of life during study period
次要结局
- Mean of clinical activity score changes (CAS Score)(baseline, 1 month, 3 months, 6 months)
- Changes of serum thyroid auto-antibodies (Anti-thyroid peroxidase (TPO), Anti-thyroglobulin)(baseline, 1 month, 3 months, 6 months)
- Changes of thyroid function test (Free T4, T3, and TSH) Levels(baseline, 1 month, 3 months, 6 months)