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The Effect of a New Antioxidant Combination (ASTED) on Mild Thyroid Eye Disease (TED)

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ClinicalTrials.gov Identifier: NCT02393183
Recruitment Status : Recruiting
First Posted : March 19, 2015
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Iran University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE March 7, 2015
First Posted Date  ICMJE March 19, 2015
Last Update Posted Date December 18, 2019
Actual Study Start Date  ICMJE July 15, 2019
Estimated Primary Completion Date June 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2017)
Change of total eye score (NOSPECS severity score) [ Time Frame: 0, 3, 6 months ]
Change of eye score during the study period
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2015)
Change of total eye score (NOSPECS severity score) [ Time Frame: 0, 3, 6 months ]
Change History Complete list of historical versions of study NCT02393183 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2017)
Change of score of thyroid eye disease Quality of life questionnaire (TED-QOL) [ Time Frame: 0, 3, 6 months ]
Change of score of thyroid eye disease Quality of life during study period
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2015)
Change of score of thyroid eye disease Quality of life questionnaire (TED-QOL) [ Time Frame: 0, 3, 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 Mild Thyroid Eye Disease (TED)
Official Title  ICMJE The Effect of a New Antioxidant Combination (ASTED) on Mild Thyroid Eye Disease, a Placebo Controlled Randomized Clinical Trial
Brief Summary

This randomized clinical trial is designed to evaluate the effect of selected antioxidant vitamins and minerals supplement:

  1. β- Carotene (3 mg)
  2. Vit C (100 mg)
  3. Vit E (Alpha-Tocopherol Acetate): 60 IU
  4. Vit D (500 IU)
  5. Zinc (4 mg, elemental)
  6. Copper (0.5 mg, elemental)
  7. Selenium 100 µg (as Sodium Selenite) in patients with mild Thyroid eye disease according to EUGOGO classification. To be given twice a day.
Detailed Description
  1. To determine total eye score (NOSPECS severity score) before and after treatment in each of the three arms of the study and make a before - after as well as an inter-arm comparison.
  2. To determine Score of thyroid eye disease Quality of life questionnaire (TED-QOL) before and after treatment in each of the three arms of the study and make a before - after as well as an inter-arm comparison.
  3. To determine clinical activity score (CAS Score) before and after treatment in each of the three arms of the study and make a before - after as well as an inter-arm comparison.
  4. To determine Serum thyroid auto-antibodies (Anti thyroid peroxidase (TPO), Anti-thyrogluboline) and Thyroid function test (Free T4, T3, and TSH) level before and after treatment in each of the three arms of the study and make a before - after as well as an inter-arm comparison.
  5. To determine the rate of side effects in each arm and make a comparison.
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: ASTED
    A tablet of ASTED will be taken twice a day
    Other Name: Antioxidant Supplement for Thyroid Eye Disease
  • Dietary Supplement: Selenium
    A tablet of 100 microgram of Selenium (same shape and color) will be taken twice a day
  • Other: Placebo
    A tablet of Placebo (same shape and color) will be taken twice a day
Study Arms  ICMJE
  • Experimental: ASTED

    Antioxidant Supplements for TED (ASTED):

    to evaluate the effect of selected antioxidant vitamins and minerals supplement (Twice daily)

    1. β- Carotene (3 mg)
    2. Vit C (100 mg)
    3. Vit E (Alpha-Tocopherol Acetate): 60 IU
    4. Vit D (500 IU)
    5. Zinc (4 mg, elemental)
    6. Copper (0.5 mg, elemental)
    7. Selenium 100 µg (as Sodium Selenite)
    Intervention: Drug: ASTED
  • Active Comparator: Selenium
    Selenium (100mic) Twice daily
    Intervention: Dietary Supplement: Selenium
  • Placebo Comparator: Placebo
    Placebo Twice daily
    Intervention: Other: 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2015)
235
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2022
Estimated Primary Completion Date June 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Mild TED of less than 18 months duration (as recorded by the patient).
  2. No active state (Clinical activity score of less than 3).
  3. No previous specific therapy for TED, except for local measures (artificial tear, head elevation, low salt diet).
  4. Euthyroidism as a result of remission after a course of antithyroid drug (ATD) therapy, or euthyroidism for at least 2 months since commencing ATD or after thyroidectomy, or euthyroidism for at least 6 months after radioiodine therapy. Hypothyroid patients after thyroidectomy or radioiodine were replaced with levothyroxine. Euthyroidism was defined as normal serum free thyroxine, total or free triiodothyronine concentrations, and thyrotropin (TSH) levels below 4 mU/Liter Patients were kept euthyroid for the whole duration of the study.
  5. Age 18-70 years.

Exclusion Criteria:

  1. TED severity of more than mild TED.
  2. Pregnancy
  3. Drug and/or alcohol abuse
  4. Severe concomitant illness
  5. Inability to comply with the study protocol
  6. No informed consent
  7. Use of selenium- or vitamin/minerals-containing preparations in the last 3 months.
  8. Developing more severe TED in the course of the trial so that requires 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
Contact: Nasser Karimi, MD +982166558811 karimi.na@iums.ac.ir
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02393183
Other Study ID Numbers  ICMJE 106955-24580-124-03-93
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
Study Director: Mohsen B Kashkouli, MD Iran University of Medical Sciences
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