The Effect of a New Antioxidant Combination (ASTED) on Mi... | NCT02393183

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

NCT02393183

Sponsor

Iran University of Medical Sciences

Status

Withdrawn

Last Update Posted

Sep 28, 2023Actual

Enrollment

0Actual

Phase

Phase 2Phase 3

Conditions

Thyroid Eye Disease

Interventions

ASTED
Selenium
Placebo

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Do not access to the drug

Expanded Access Info

Start Date

Jul 15, 2019Actual

Primary Completion Date

Jun 15, 2022Estimated

Completion Date

Dec 15, 2022Estimated

First Submitted Date

Mar 7, 2015

First Submission Date that Met QC Criteria

Mar 14, 2015

First Posted Date

Mar 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2023

Last Update Posted Date

Sep 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ASTED	Experimental	Antioxidant Supplements for TED (ASTED): to evaluate the effect of selected antioxidant vitamins and minerals supplement (Twice daily) 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)	Drug: ASTED
Selenium	Active Comparator	Selenium (100mic) Twice daily	Dietary Supplement: Selenium
Placebo	Placebo Comparator	Placebo Twice daily	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ASTED	Drug	A tablet of ASTED will be taken twice a day	ASTED	Antioxidant Supplement for Thyroid Eye Disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of total eye score (NOSPECS severity score)	Change of eye score during the study period	0, 3, 6 months

Secondary Outcomes

Measure	Description	Time Frame
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	0, 3, 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D015785	Eye Diseases, Hereditary
D005128	Eye Diseases
D006111	Graves Disease
D005094	Exophthalmos

ID	Term
D018011	Chalcogens
D004602	Elements
D007287	Inorganic Chemicals
D008903	Minerals