Study on Efficacy of Add on Selenium in Mild-to-moderate Graves Ophthalmopathy

Thyroid Eye Disease Clinical Trial

Official title:

Study on Efficacy of Add on Selenium in Mild-to-moderate Graves Ophthalmopathy: A Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06413043
• Other study ID #: PG Thesis/2023-24/122
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: November 5, 2025

Study information

• Verified date: May 2024
• Source: All India Institute of Medical Sciences, Bhubaneswar
• Contact: Sandip Sahu Dr Associate Professor, MS
• Phone: +917978243970
• Email: ophthal_sandip[@]aiimsbhubaneswar.edu.in
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: November 5, 2025
• Est. primary completion date: August 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Eye Disease

Intervention

Drug:
• Selenium
Add on Selenium (100mcg once daily) with Vitamin B Complex and Standard Treatment for Grave's Disease

Locations

Country	Name	City	State
India	AIIMS Bhubaneswar	Bhubaneswar	Odisha

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, Bhubaneswar

Country where clinical trial is conducted

India, 

References & Publications (3)

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. — View 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;1 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate and compare the response of add on selenium in patients with grave's ophthalmopathy	To evaluate and compare the response of add on selenium in patients with grave's ophthalmopathy, with Best corrected visual Acuity, Clinical activity Score (CAS ), Increase in measured proptosis (bulging of the eyes) > 2 mm over 1-3 months. Decrease in eye movement limit of > 8° over 1-3 months. Decrease in visual acuity (2 Snellen chart lines) over 1-3 months. A CAS score greater than 4 is associated with active disease. The positive predictive value of CAS > 4 is approximately 80%, and the negative predictive value is around 64%	90 Days
Secondary	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	To study 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, through the World Health Organization Quality of Life Brief Version- Brief(WHOQOL-BRIEF) questionnaire.; The 4 domain scores are each converted into a scale from 0 to 100. For this purpose, the number 4 is subtracted from each of the domain scores, and the difference is multiplied by 100/16 or the number 6.25. 0 points represent the worst possible state of health, while 100 points represent the best possible state of health with regard to the respective domain. Thus, the patient's physical, psychological, social, and environmental state of health are assessed separately.	90 Days
Secondary	To Assess the Colour Vison	Anomaloscopes are optical instruments in which the observer must manipulate stimulus control knobs to match two colored fields in color and brightness.; Measurement Unit: Typically, color vision is assessed qualitatively (normal or deficient).; Minimum Value: Normal color vision (able to perceive a wide range of colors). Maximum Value: Color vision deficiency (varies based on the type of deficiency).	90 Days
Secondary	To Assess the Fundus	Fundus Examination: Measurement Unit: No specific unit; it's a visual assessment. Minimum Value: Normal fundus appearance (no abnormalities). Maximum Value: Various abnormalities (e.g., diabetic retinopathy, hypertensive retinopathy).	90 Days
Secondary	To Examine Thyroid Function Test	Thyroid Function Test: TSH: Normal range is approximately 0.4 to 4.0 µIU/mL. T4: Normal range is around 4.5 to 11.2 µg/dL. T3: Normal range varies but is generally 80 to 200 ng/dL	90 Days