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

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ClinicalTrials.gov Identifier: NCT02422368
Recruitment Status : Not yet recruiting
First Posted : April 21, 2015
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Iran University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Thyroid Eye Disease Drug: Methylprednisolone + ASTED Drug: Methylprednisolone +Placebo Phase 2 Phase 3

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:

  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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
Experimental: 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.

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.


Placebo Comparator: Methylprednisolone + Placebo
Placebo Twice a day for 6 months Methylprednisolone prescribes as the same as arm 1
Drug: 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.





Primary Outcome Measures :
  1. Mean of total eye score changes (using NOSPECS severity score) [ Time Frame: baseline, 1 month, 3 months, 6 months ]
    Total eye score change during study

  2. Mean of "thyroid eye disease Quality of life" score changes (Using TED-QOL) [ Time Frame: baseline, 1 month, 3 months, 6 months ]
    Changing quality of life during study period


Secondary Outcome Measures :
  1. Mean of clinical activity score changes (CAS Score) [ Time Frame: baseline, 1 month, 3 months, 6 months ]
    Change of clinical activity score during study period

  2. Changes of serum thyroid auto-antibodies (Anti-thyroid peroxidase (TPO), Anti-thyroglobulin) [ Time Frame: baseline, 1 month, 3 months, 6 months ]
    Change of serum thyroid auto-antibodies during study period

  3. Changes of thyroid function test (Free T4, T3, and TSH) Levels [ Time Frame: baseline, 1 month, 3 months, 6 months ]
    Change of thyroid function test during study period



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422368


Contacts
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Contact: Mohsen B Kashkouli, MD 009866558811 mkashkouli2@gmail.com

Locations
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Iran, Islamic Republic of
Private Thyroid eye disease clinic Not yet recruiting
Tehran, Iran, Islamic Republic of, 14455
Rassoul Akram Hospital Recruiting
Tehran, Iran, Islamic Republic of
Contact: Mohsen B Kashkouli, MD         
Sponsors and Collaborators
Iran University of Medical Sciences
Investigators
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Principal Investigator: Mohsen B Kashkouli, MD IUMS

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Responsible Party: Iran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02422368     History of Changes
Other Study ID Numbers: 93-02-124-24581
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Iran University of Medical Sciences:
Graves' ophthalmopathy
Antioxidant
Activity
Severity
Additional relevant MeSH terms:
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Graves Ophthalmopathy
Thyroid Diseases
Eye Diseases
Endocrine System Diseases
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
Orbital Diseases
Genetic Diseases, Inborn
Goiter
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Antioxidants
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists