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

NCT02422368 | Withdrawn Phase 2

• 1 other identifier: 93-02-124-24581
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Thyroid Eye Disease

Keywords

Graves' ophthalmopathy; Antioxidant; Activity; Severity

Outcome Measures

Primary Outcomes (2)

• Mean of total eye score changes (using NOSPECS severity score)

  Total eye score change during study

  baseline, 1 month, 3 months, 6 months

• 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 Outcomes (3)

• 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

Study Arms (2)

Methylprednisolone + ASTED

EXPERIMENTAL

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.

Drug: Methylprednisolone + ASTED

Methylprednisolone + Placebo

PLACEBO COMPARATOR

Placebo Twice a day for 6 months Methylprednisolone prescribes as the same as arm 1

Drug: Methylprednisolone +Placebo

Interventions

Methylprednisolone + ASTED DRUG

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 + ASTED

Methylprednisolone +Placebo DRUG

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.

Methylprednisolone + Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Iran University of Medical Sciences: lead

Study Sites (2)

Private Thyroid eye disease clinic

Tehran, 14455, Iran

Location

Rassoul Akram Hospital

Tehran, Iran

Location

MeSH Terms

Conditions

Graves Ophthalmopathy; Motor Activity

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mohsen B Kashkouli, MD

  IUMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2015
• First Posted: April 21, 2015
• Study Start: September 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 10, 2022

Record last verified: 2021-01

Locations

IR (2)