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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

Tracking Information
First Submitted Date  ICMJE April 11, 2015
First Posted Date  ICMJE April 21, 2015
Last Update Posted Date August 6, 2019
Estimated Study Start Date  ICMJE November 1, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2017)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 16, 2015)
  • Mean of total eye score changes (using NOSPECS severity score) [ Time Frame: baseline, 1 month, 3 months, 6 months ]
  • Mean of "thyroid eye disease Quality of life" score changes (Using TED-QOL) [ Time Frame: baseline, 1 month, 3 months, 6 months ]
Change History Complete list of historical versions of study NCT02422368 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2017)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2015)
  • Mean of clinical activity score changes (CAS Score) [ Time Frame: baseline, 1 month, 3 months, 6 months ]
  • Changes of serum thyroid auto-antibodies (Anti-thyroid peroxidase (TPO), Anti-thyroglobulin) [ Time Frame: baseline, 1 month, 3 months, 6 months ]
  • Changes of thyroid function test (Free T4, T3, and TSH) Levels [ Time Frame: baseline, 1 month, 3 months, 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease
Official Title  ICMJE The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease, a Double Blind Placebo Controlled Randomized Clinical Trial
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:

  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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Thyroid Eye Disease
Intervention  ICMJE
  • 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.

  • 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.

Study Arms  ICMJE
  • 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.

    Intervention: Drug: Methylprednisolone + ASTED
  • Placebo Comparator: Methylprednisolone + Placebo
    Placebo Twice a day for 6 months Methylprednisolone prescribes as the same as arm 1
    Intervention: Drug: Methylprednisolone +Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2015)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mohsen B Kashkouli, MD 009866558811 mkashkouli2@gmail.com
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02422368
Other Study ID Numbers  ICMJE 93-02-124-24581
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Iran University of Medical Sciences
Study Sponsor  ICMJE Iran University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohsen B Kashkouli, MD IUMS
PRS Account Iran University of Medical Sciences
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP