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Trial record 29 of 8394 for:    Ophthalmopathy

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

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ClinicalTrials.gov Identifier: NCT02393183
Recruitment Status : Not yet recruiting
First Posted : March 19, 2015
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Iran University of Medical Sciences

Brief Summary:
This randomized clinical trial is designed to evaluate the effect of selected antioxidant vitamins and minerals supplement B-Carotene (6 mg) + Vit.C (200 mg) + Vit.E (200 mg) + Vit. Nicotinamide (20 mg) + Selenium (200 mic.)+ Zinc oxide (8 mg) + Copper oxide (1mg) +Mangeneschloride (1.8 mg) in patients with mild Graves' orbitopathy according to EUGOGO classification.

Condition or disease Intervention/treatment Phase
Thyroid Eye Disease Drug: ASTED Dietary Supplement: Selenium Other: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 235 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 Mild Thyroid Eye Disease, a Placebo Controlled Randomized Clinical Trial
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Arm Intervention/treatment
Experimental: ASTED

Antioxidant Supplements for TED:

to evaluate the effect of selected antioxidant vitamins and minerals supplement B-Carotene (6 mg) + Vit.C (200 mg) + Vit.E (200 mg) + Vit. Nicotinamide (20 mg) + Selenium (200 mic.)+ Zinc oxide (8 mg) + Copper oxide (1mg) +Mangeneschloride (1.8 mg)

Drug: ASTED
A tablet of ASTED will be taken twice a day
Other Name: Antioxidant Supplement for Thyroid Eye Disease

Active Comparator: Selenium
Selenium (200mic)
Dietary Supplement: Selenium
A tablet of 100 microgram of Selenium (same shape and color) will be taken twice a day

Placebo Comparator: Placebo
Placebo
Other: Placebo
A tablet of Placebo (same shape and color) will be taken twice a day




Primary Outcome Measures :
  1. Change of total eye score (NOSPECS severity score) [ Time Frame: 0, 3, 6 months ]
    Change of eye score during the study period


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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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:

  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.

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): NCT02393183


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

Locations
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Iran, Islamic Republic of
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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Study Director: Mohsen B Kashkouli, MD Iran University of Medical Sciences

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Responsible Party: Iran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02393183     History of Changes
Other Study ID Numbers: 106955-24580-124-03-93
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: February 27, 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:
Antioxidant
Graves' ophthalmopathy
Thyroid eye disease
Severity score
Activity score
Quality of life

Additional relevant MeSH terms:
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Eye Diseases
Graves Ophthalmopathy
Eye Diseases, Hereditary
Thyroid Diseases
Endocrine System Diseases
Graves Disease
Exophthalmos
Orbital Diseases
Genetic Diseases, Inborn
Goiter
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Antioxidants
Selenium
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Nutrients
Growth Substances