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

NCT06413043 | Not Yet Recruiting

• 1 other identifier: PG Thesis/2023-24/122
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Eye Disease; Graves Ophthalmopathy

Keywords

Thyroid Eye Disease; Graves Ophthalmopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  90 Days

• To Assess the Colour Vison

  90 Days

• To Assess the Fundus

  90 Days

• To Examine Thyroid Function Test

  90 Days

Study Arms (2)

ADD on Selenium

ACTIVE COMPARATOR

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

Drug: Selenium

Placebo

NO INTERVENTION

Vitamin B Complex supplementation with Standard Treatment for Grave's Disease

Interventions

Selenium DRUG

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

ADD on Selenium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

AIIMS Bhubaneswar

Bhubaneswar, Odisha, 751019, India

Location

Related 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.

  PMID: 35604323 RESULT

• 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.

  PMID: 36479875 RESULT

• 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.

  PMID: 33574798 RESULT

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

Selenium

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals

Central Study Contacts

Sandip Sahu Dr Associate Professor, MS

CONTACT

+917978243970; ophthal_sandip@aiimsbhubaneswar.edu.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 14, 2024
• Study Start: May 6, 2024
• Primary Completion: August 5, 2025
• Study Completion: November 5, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)