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

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Iran University of Medical Sciences
• Treatments: Antioxidants; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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.