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

Primary Purpose

Thyroid Eye Disease

Status
Withdrawn
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Methylprednisolone + ASTED
Methylprednisolone +Placebo
Sponsored by
Iran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Eye Disease focused on measuring Graves' ophthalmopathy, Antioxidant, Activity, Severity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Private Thyroid eye disease clinic
  • Rassoul Akram Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methylprednisolone + ASTED

Methylprednisolone + Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Mean of total eye score changes (using NOSPECS severity score)
Total eye score change during study
Mean of "thyroid eye disease Quality of life" score changes (Using TED-QOL)
Changing quality of life during study period

Secondary Outcome Measures

Mean of clinical activity score changes (CAS Score)
Change of clinical activity score during study period
Changes of serum thyroid auto-antibodies (Anti-thyroid peroxidase (TPO), Anti-thyroglobulin)
Change of serum thyroid auto-antibodies during study period
Changes of thyroid function test (Free T4, T3, and TSH) Levels
Change of thyroid function test during study period

Full Information

First Posted
April 11, 2015
Last Updated
December 18, 2021
Sponsor
Iran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02422368
Brief Title
The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Do not access to the drug
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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: 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. Score of thyroid eye disease Quality of life questionnaire (TED-QOL) 2. Secondary outcomes measures: To compare possible change in: Clinical activity score (CAS Score) 3 (7 items are scored in the beginning and 10 items are scored at 3 and 6 months) 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 Side effects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Eye Disease
Keywords
Graves' ophthalmopathy, Antioxidant, Activity, Severity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylprednisolone + ASTED
Arm Type
Experimental
Arm Description
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.
Arm Title
Methylprednisolone + Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Twice a day for 6 months Methylprednisolone prescribes as the same as arm 1
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone + ASTED
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone +Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean of total eye score changes (using NOSPECS severity score)
Description
Total eye score change during study
Time Frame
baseline, 1 month, 3 months, 6 months
Title
Mean of "thyroid eye disease Quality of life" score changes (Using TED-QOL)
Description
Changing quality of life during study period
Time Frame
baseline, 1 month, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Mean of clinical activity score changes (CAS Score)
Description
Change of clinical activity score during study period
Time Frame
baseline, 1 month, 3 months, 6 months
Title
Changes of serum thyroid auto-antibodies (Anti-thyroid peroxidase (TPO), Anti-thyroglobulin)
Description
Change of serum thyroid auto-antibodies during study period
Time Frame
baseline, 1 month, 3 months, 6 months
Title
Changes of thyroid function test (Free T4, T3, and TSH) Levels
Description
Change of thyroid function test during study period
Time Frame
baseline, 1 month, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohsen B Kashkouli, MD
Organizational Affiliation
IUMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Private Thyroid eye disease clinic
City
Tehran
ZIP/Postal Code
14455
Country
Iran, Islamic Republic of
Facility Name
Rassoul Akram Hospital
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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