The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease

Thyroid Eye Disease Clinical Trial

Official title:

The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease, a Double Blind Placebo Controlled Randomized Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02422368
• Other study ID #: 93-02-124-24581
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: September 1, 2022
• Est. completion date: November 2024

Study information

• Verified date: January 2021
• Source: Iran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

1. 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:

1. Clinical activity score (CAS Score) 3 (7 items are scored in the beginning and 10 items are scored at 3 and 6 months)

2. Serum thyroid auto-antibodies (Anti-thyroid peroxidase (TPO), Anti-thyroglobulin) at 0, 3 and 6 months. Thyroid function test (Free T4, T3, and TSH) will be measured in all 3 visits0

3. Side effects

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Diseases
• Thyroid Eye Disease

Intervention

Drug:
• Methylprednisolone + ASTED
ASTED tablet: Twice daily for 6 months Methylprednisolone: 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 ups.
• Methylprednisolone +Placebo
Placebo: twice daily Methylprednisolone: 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 ups.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Private Thyroid eye disease clinic	Tehran
Iran, Islamic Republic of	Rassoul Akram Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Iran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean of total eye score changes (using NOSPECS severity score)	Total eye score change during study	baseline, 1 month, 3 months, 6 months
Primary	Mean of "thyroid eye disease Quality of life" score changes (Using TED-QOL)	Changing quality of life during study period	baseline, 1 month, 3 months, 6 months
Secondary	Mean of clinical activity score changes (CAS Score)	Change of clinical activity score during study period	baseline, 1 month, 3 months, 6 months
Secondary	Changes of serum thyroid auto-antibodies (Anti-thyroid peroxidase (TPO), Anti-thyroglobulin)	Change of serum thyroid auto-antibodies during study period	baseline, 1 month, 3 months, 6 months
Secondary	Changes of thyroid function test (Free T4, T3, and TSH) Levels	Change of thyroid function test during study period	baseline, 1 month, 3 months, 6 months