Thyroid Eye DiseasePhase 2/3NCT02393183
The Effect of a New Antioxidant Combination (ASTED) on Mild Thyroid Eye Disease (TED)
A Phase 2/3 study testing ASTED and Selenium in people with Thyroid Eye Disease, run by Iran University of Medical Sciences at 1 site in Iran.
Trial summary
This randomized clinical trial is designed to evaluate the effect of selected antioxidant vitamins and minerals supplement named as ASTED: 1. β- Carotene (30 mg) 2. Vit C (100 mg) 3. Vit E (Alpha-Tocopherol Acetate): 60-200 IU 4. Calcium phosphate dihydrate (40 mg) 5. Zinc oxide (4 mg, elemental) 6. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- ASTED and Selenium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIran
- Study dates
- 15 Jul 2019to 15 Dec 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid Eye Disease
- Being tested
- ASTED, Selenium, Placebo
- Keywords
- Antioxidant, Graves' ophthalmopathy, Thyroid eye disease, Severity score, Activity score, Quality of life
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASTEDDrug
Also called Antioxidant Supplement for Thyroid Eye Disease
A tablet of ASTED will be taken twice a day
SeleniumDietary supplement
A tablet of 100 microgram of Selenium (same shape and color) will be taken twice a day
PlaceboOther
A tablet of Placebo (same shape and color) will be taken twice a day
| Study group | Role | What they receive |
|---|---|---|
| ASTED | Experimental | Antioxidant Supplements for TED (ASTED):
to evaluate the effect of selected antioxidant vitamins and minerals supplement (Twice daily)
1. β- Carotene (30 mg)
2. Vit C (100 mg)
3. Vit E (Alpha-Tocopherol Acetate): 60-200 IU
4. Calcium phosphate dihydrate (40 mg)
5. Zinc oxide (4 mg, elemental)
6. Copper gluconate (3.5 mg)
7. Sodium selenite 23 mg= Selenium 100 µg
8. Nicotinamide (a form of vit.B3) (10 mg) Receives: Drug: ASTED |
| Selenium | Active comparator | Selenium (100mic) Twice daily Receives: Dietary Supplement: Selenium |
| Placebo | Placebo comparator | Placebo Twice daily Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of total eye score (NOSPECS severity score)
Change of eye score during the study period
Measured: 0, 3, 6 months
Secondary outcomes (1)
Change of score of thyroid eye disease Quality of life questionnaire (TED-QOL)
Change of score of thyroid eye disease Quality of life during study period
Measured: 0, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study start15 Jul 2019
- Primary completion15 Jun 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Why it stopped: Do not access to the drug
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohsen B Kashkouli, MD, Study director, Iran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393183
- Sponsor's protocol ID
- 106955-24580-124-03-93
- Status last verified
- Sep 2023
- First submitted
- 7 Mar 2015
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a New Antioxidant Combination (ASTED) on Mild Thyroid Eye Disease, a Placebo Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02393183
- Acronym / sponsor ID
- 106955-24580-124-03-93
- Conditions
- Thyroid Eye Disease
- Keywords
- Antioxidant, Graves' ophthalmopathy, Thyroid eye disease, Severity score, Activity score, Quality of life
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Do not access to the drug
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Iran University of Medical SciencesUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASTED | Experimental | Drug: ASTEDAntioxidant Supplements for TED (ASTED): to evaluate the effect of selected antioxidant vitamins and minerals supplement (Twice daily) 1. β- Carotene (30 mg) 2. Vit C (100 mg) 3. Vit E (Alpha-Tocopherol Acetate): 60-200 IU 4. Calcium phosphate dihydrate (40 mg) 5. Zinc oxide (4 mg, elemental) 6. Copper gluconate (3.5 mg) 7. Sodium selenite 23 mg= Selenium 100 µg 8. Nicotinamide (a form of vit.B3) (10 mg) |
| Selenium | Active comparator | Dietary Supplement: SeleniumSelenium (100mic) Twice daily |
| Placebo | Placebo comparator | Other: PlaceboPlacebo Twice daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- TED severity of more than mild TED.
- Pregnancy
- Drug and/or alcohol abuse
- Severe concomitant illness
- Inability to comply with the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASTEDAlso: Antioxidant Supplement for Thyroid Eye DiseaseA tablet of ASTED will be taken twice a day | Drug | ASTED |
| SeleniumA tablet of 100 microgram of Selenium (same shape and color) will be taken twice a day | Dietary supplement | Selenium |
| PlaceboA tablet of Placebo (same shape and color) will be taken twice a day | Other | Placebo |
Primary outcome
Change of total eye score (NOSPECS severity score)
Time frame: 0, 3, 6 months
Change of eye score during the study period
1 secondary outcome
Change of score of thyroid eye disease Quality of life questionnaire (TED-QOL)
Time frame: 0, 3, 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohsen B Kashkouli, MD study director
Iran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ASTED and Selenium in people with Thyroid Eye Disease, run by Iran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of total eye score (NOSPECS severity score) (time frame: 0, 3, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.