Clinical trial NCT06413043: Study on Efficacy of Add on Selenium in Mild-to-moderate Graves Ophthalmopathy
Official title: Study on Efficacy of Add on Selenium in Mild-to-moderate Graves Ophthalmopathy: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Thyroid Eye Disease
Graves Ophthalmopathy
Keywords: Thyroid Eye Disease
Graves Ophthalmopathy
Lead sponsor: All India Institute of Medical Sciences, Bhubaneswar
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Study on efficacy of add on selenium in mild-to-moderate Graves ophthalmopathy: A Randomized Control Trial.; The study aims to evaluate the response of adding selenium in patients with Graves ophthalmopathy, focusing on improving quality of life, CAS scoring, and thyroid status. The methodology involves a Randomized Control Trial with a sample size of 78 patients. Patients meeting specific criteria will receive either standard treatment with Anti Thyroid Drugs and Vitamin B complex or add on selenium with Vitamin B complex for 6 months. Outcome measures include CAS score reduction, thyroid function improvement, and quality of life enhancement. The study will last 18 months, with various investigations and ethical considerations outlined. The document emphasizes the importance of early diagnosis of Graves Ophthalmopathy to prevent vision loss and deformity, highlighting the significance of informed patients and healthcare professionals regarding TED symptoms and risk factors.

Detailed description: The Study on efficacy of add on selenium in mild-to-moderate Graves ophthalmopathy: A Randomized Control Trial. The study aims to evaluate the response of adding selenium in patients with Graves ophthalmopathy, focusing on improving quality of life, CAS scoring, and thyroid status. The methodology involves a Randomized Control Trial with a sample size of 78 patients. Patients meeting specific criteria will receive either standard treatment with Anti Thyroid Drugs and Vitamin B complex or add on selenium with Vitamin B complex for 6 months. Outcome measures include CAS score reduction, thyroid function improvement, and quality of life enhancement. The study will last 18 months, with various investigations and ethical considerations outlined. The document emphasizes the importance of early diagnosis of Graves Ophthalmopathy to prevent vision loss and deformity, highlighting the significance of informed patients and healthcare professionals regarding TED symptoms and risk factors.

Eligibility criteria: Inclusion Criteria:

* Patients with Mild-to-moderate Grave's Ophthalmopathy in Age group \>18years

With only one or more :

* Retraction of lid \<2 mm
* Mild soft tissue involvement
* Proptosis of \<=3 mm
* Corneal exposure that responds to lubricating eyedrops.
* Patients with CAS \< = 4
* Patients diagnosed with hyperthyroidism converted to euthyroid since 2 months with Anti Thyroid Drugs.
* Those who are willing to follow the advised treatment and timely follow ups.

Exclusion Criteria:

* Treatment with any steroid (Intravenous, oral or topical) for any condition within 3 weeks before presentation.
* Any treatment with rituximab
* Any earlier treatment with teprotumumab.
* Any treatment with monoclonal antibody within 3months before presentation.
* Lactating or pregnant women

Primary outcomes:
measure: To evaluate and compare the response of add on selenium in patients with grave's ophthalmopathy
timeFrame: 90 Days
Secondary outcomes:
measure: the effects of Grave's ophthalmopathy on Patient's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns
timeFrame: 90 Days
measure: To Assess the Colour Vison
timeFrame: 90 Days
measure: To Assess the Fundus
timeFrame: 90 Days
measure: To Examine Thyroid Function Test
timeFrame: 90 Days
Other outcomes:
Locations:
city: Bhubaneswar
country: India
facility: AIIMS Bhubaneswar
state: Odisha
Study officials:
References:
citation: Bartalena L, Tanda ML. Current concepts regarding Graves' orbitopathy. J Intern Med. 2022 Nov;292(5):692-716. doi: 10.1111/joim.13524. Epub 2022 Jun 1.
citation: Burch HB, Perros P, Bednarczuk T, Cooper DS, Dolman PJ, Leung AM, Mombaerts I, Salvi M, Stan MN. Management of thyroid eye disease: a Consensus Statement by the American Thyroid Association and the European Thyroid Association. Eur Thyroid J. 2022 Dec 8;11(6):e220189. doi: 10.1530/ETJ-22-0189. Print 2022 Dec 1.
citation: Lanzolla G, Marino M, Marcocci C. Selenium in the Treatment of Graves' Hyperthyroidism and Eye Disease. Front Endocrinol (Lausanne). 2021 Jan 26;11:608428. doi: 10.3389/fendo.2020.608428. eCollection 2020.