Clinical trial NCT02422368: The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease
Official title: The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease, a Double Blind Placebo Controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Thyroid Eye Disease
Keywords: Graves' ophthalmopathy
Antioxidant
Activity
Severity
Lead sponsor: Iran University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

1. 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.

   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.
2. Score of thyroid eye disease Quality of life questionnaire (TED-QOL) 2.

Secondary outcomes measures:

To compare possible change in:

1. Clinical activity score (CAS Score) 3 (7 items are scored in the beginning and 10 items are scored at 3 and 6 months)
2. 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
3. Side effects

Eligibility criteria: Inclusion Criteria:

* Moderate to severe TED of less than 18 months duration:
* Active state (Clinical activity score of 3 and more).
* No steroid and or any supplement treatment for the last 6 months.
* Euthyroidism
* Age 18-70 years.

Exclusion Criteria:

* Sight-threatening TED
* Pregnancy
* Drug and/or alcohol abuse
* Severe concomitant illness
* Inability to comply with the study protocol
* No informed consent
* Developing more severe TED (Sight threatening TED) in the course of the trial.
* Contraindications of steroid treatment.

Primary outcomes:
measure: Mean of total eye score changes (using NOSPECS severity score)
timeFrame: baseline, 1 month, 3 months, 6 months
measure: Mean of "thyroid eye disease Quality of life" score changes (Using TED-QOL)
timeFrame: baseline, 1 month, 3 months, 6 months
Secondary outcomes:
measure: Mean of clinical activity score changes (CAS Score)
timeFrame: baseline, 1 month, 3 months, 6 months
measure: Changes of serum thyroid auto-antibodies (Anti-thyroid peroxidase (TPO), Anti-thyroglobulin)
timeFrame: baseline, 1 month, 3 months, 6 months
measure: Changes of thyroid function test (Free T4, T3, and TSH) Levels
timeFrame: baseline, 1 month, 3 months, 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Private Thyroid eye disease clinic
city: Tehran
country: Iran, Islamic Republic of
facility: Rassoul Akram Hospital
Study officials:
affiliation: IUMS
name: Mohsen B Kashkouli, MD
role: PRINCIPAL_INVESTIGATOR
References: