Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT02422368
Status:
WITHDRAWN
Last Update Posted:
2022-01-10
First Post:
2015-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D049970', 'term': 'Graves Ophthalmopathy'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Do not access to the drug', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-18', 'studyFirstSubmitDate': '2015-04-11', 'studyFirstSubmitQcDate': '2015-04-16', 'lastUpdatePostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean of total eye score changes (using NOSPECS severity score)', 'timeFrame': 'baseline, 1 month, 3 months, 6 months', 'description': 'Total eye score change during study'}, {'measure': 'Mean of "thyroid eye disease Quality of life" score changes (Using TED-QOL)', 'timeFrame': 'baseline, 1 month, 3 months, 6 months', 'description': 'Changing quality of life during study period'}], 'secondaryOutcomes': [{'measure': 'Mean of clinical activity score changes (CAS Score)', 'timeFrame': 'baseline, 1 month, 3 months, 6 months', 'description': 'Change of clinical activity score during study period'}, {'measure': 'Changes of serum thyroid auto-antibodies (Anti-thyroid peroxidase (TPO), Anti-thyroglobulin)', 'timeFrame': 'baseline, 1 month, 3 months, 6 months', 'description': 'Change of serum thyroid auto-antibodies during study period'}, {'measure': 'Changes of thyroid function test (Free T4, T3, and TSH) Levels', 'timeFrame': 'baseline, 1 month, 3 months, 6 months', 'description': 'Change of thyroid function test during study period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Graves' ophthalmopathy", 'Antioxidant', 'Activity', 'Severity'], 'conditions': ['Thyroid Eye Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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:\n\n1. 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.\n\n 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.\n2. Score of thyroid eye disease Quality of life questionnaire (TED-QOL) 2.\n\nSecondary outcomes measures:\n\nTo compare possible change in:\n\n1. Clinical activity score (CAS Score) 3 (7 items are scored in the beginning and 10 items are scored at 3 and 6 months)\n2. 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\n3. Side effects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe TED of less than 18 months duration:\n* Active state (Clinical activity score of 3 and more).\n* No steroid and or any supplement treatment for the last 6 months.\n* Euthyroidism\n* Age 18-70 years.\n\nExclusion Criteria:\n\n* Sight-threatening TED\n* Pregnancy\n* Drug and/or alcohol abuse\n* Severe concomitant illness\n* Inability to comply with the study protocol\n* No informed consent\n* Developing more severe TED (Sight threatening TED) in the course of the trial.\n* Contraindications of steroid treatment.'}, 'identificationModule': {'nctId': 'NCT02422368', 'briefTitle': 'The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease', 'organization': {'class': 'OTHER', 'fullName': 'Iran University of Medical Sciences'}, 'officialTitle': 'The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease, a Double Blind Placebo Controlled Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '93-02-124-24581'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methylprednisolone + ASTED', 'description': '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\n\nMethylprednisolone includes :\n\nMethylprednisolone 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.', 'interventionNames': ['Drug: Methylprednisolone + ASTED']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Methylprednisolone + Placebo', 'description': 'Placebo Twice a day for 6 months Methylprednisolone prescribes as the same as arm 1', 'interventionNames': ['Drug: Methylprednisolone +Placebo']}], 'interventions': [{'name': 'Methylprednisolone + ASTED', 'type': 'DRUG', 'description': 'ASTED tablet: Twice daily for 6 months\n\nMethylprednisolone:\n\nMethylprednisolone 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.', 'armGroupLabels': ['Methylprednisolone + ASTED']}, {'name': 'Methylprednisolone +Placebo', 'type': 'DRUG', 'description': 'Placebo: twice daily\n\nMethylprednisolone:\n\nMethylprednisolone 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.', 'armGroupLabels': ['Methylprednisolone + Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14455', 'city': 'Tehran', 'country': 'Iran', 'facility': 'Private Thyroid eye disease clinic', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'Rassoul Akram Hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Mohsen B Kashkouli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IUMS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}