- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02393183
The Effect of a New Antioxidant Combination (ASTED) on Mild Thyroid Eye Disease (TED)
September 26, 2023 updated by: Iran University of Medical Sciences
The Effect of a New Antioxidant Combination (ASTED) on Mild Thyroid Eye Disease, a Placebo Controlled Randomized Clinical Trial
This randomized clinical trial is designed to evaluate the effect of selected antioxidant vitamins and minerals supplement named as ASTED:
- β- Carotene (30 mg)
- Vit C (100 mg)
- Vit E (Alpha-Tocopherol Acetate): 60-200 IU
- Calcium phosphate dihydrate (40 mg)
- Zinc oxide (4 mg, elemental)
- Copper gluconate (3.5 mg)
- Sodium selenite 23 mg= Selenium 100 µg
- Nicotinamide (a form of vit.B3) (10 mg)
in patients with mild Thyroid eye disease according to EUGOGO classification. To be given twice a day.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
- 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.
- 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.
- 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.
- 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.
- To determine the rate of side effects in each arm and make a comparison.
Study Type
Interventional
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tehran, Iran, Islamic Republic of
- Rassoul Akram Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Mild TED of less than 18 months duration (as recorded by the patient).
- No active state (Clinical activity score of less than 3).
- No previous specific therapy for TED, except for local measures (artificial tear, head elevation, low salt diet).
- 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.
- Age 18-70 years.
Exclusion Criteria:
- TED severity of more than mild TED.
- Pregnancy
- Drug and/or alcohol abuse
- Severe concomitant illness
- Inability to comply with the study protocol
- No informed consent
- Use of selenium- or vitamin/minerals-containing preparations in the last 3 months.
- Developing more severe TED in the course of the trial so that requires steroid treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Selenium
Selenium (100mic) Twice daily
|
A tablet of 100 microgram of Selenium (same shape and color) will be taken twice a day
|
Placebo Comparator: Placebo
Placebo Twice daily
|
A tablet of Placebo (same shape and color) will be taken twice a day
|
Experimental: ASTED
Antioxidant Supplements for TED (ASTED): to evaluate the effect of selected antioxidant vitamins and minerals supplement (Twice daily)
|
A tablet of ASTED will be taken twice a day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of total eye score (NOSPECS severity score)
Time Frame: 0, 3, 6 months
|
Change of eye score during the study period
|
0, 3, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
0, 3, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Mohsen B Kashkouli, MD, Iran University of Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2019
Primary Completion (Estimated)
June 15, 2022
Study Completion (Estimated)
December 15, 2022
Study Registration Dates
First Submitted
March 7, 2015
First Submitted That Met QC Criteria
March 14, 2015
First Posted (Estimated)
March 19, 2015
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 26, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Genetic Diseases, Inborn
- Eye Diseases, Hereditary
- Graves Disease
- Exophthalmos
- Orbital Diseases
- Goiter
- Hyperthyroidism
- Eye Diseases
- Graves Ophthalmopathy
- Thyroid Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Trace Elements
- Micronutrients
- Antioxidants
- Selenium
Other Study ID Numbers
- 106955-24580-124-03-93
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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