## Protocol Section
### Identification Module
**NCT ID:** NCT06413043

**Brief Title:** 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

#### Organization Study ID Info
**ID:** PG Thesis/2023-24/122
#### Organization
**Class:** OTHER
**Full Name:** All India Institute of Medical Sciences, Bhubaneswar
### Status Module
#### Completion Date
**Date:** 2025-11-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-11

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-08-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** All India Institute of Medical Sciences, Bhubaneswar

#### Responsible Party

**Investigator Affiliation:** All India Institute of Medical Sciences, Bhubaneswar

**Investigator Full Name:** Sandip Kumar Sahu

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Thyroid Eye Disease

- Graves Ophthalmopathy

**Keywords:**

- Thyroid Eye Disease

- Graves Ophthalmopathy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 78

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Selenium

**Label:** ADD on Selenium

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Label:** Placebo

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ADD on Selenium

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

**Name:** Selenium

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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%

**Measure:** To evaluate and compare the response of add on selenium in patients with grave's ophthalmopathy

**Time Frame:** 90 Days

#### Secondary Outcomes

**Description:** 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.

**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

**Time Frame:** 90 Days

**Description:** 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).

**Measure:** To Assess the Colour Vison

**Time Frame:** 90 Days

**Description:** 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).

**Measure:** To Assess the Fundus

**Time Frame:** 90 Days

**Description:** 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

**Measure:** To Examine Thyroid Function Test

**Time Frame:** 90 Days

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ophthal_sandip@aiimsbhubaneswar.edu.in

**Name:** Sandip Sahu Dr Associate Professor, MS

**Phone:** +917978243970

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bhubaneswar

**Contacts:**

***Contact 1:***

- **Email:** iec@aiimsbhubaneswar.edu.in

- **Name:** Ashutosh Biswas Director, MD

- **Phone:** 917978243970

- **Role:** CONTACT

**Country:** India

**Facility:** AIIMS Bhubaneswar

**State:** Odisha

**Zip:** 751019

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 35604323

**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.

**PMID:** 36479875

**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.

**PMID:** 33574798

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013959

- Term: Thyroid Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000015785

- Term: Eye Diseases, Hereditary

- ID: D000006111

- Term: Graves Disease

- ID: D000005094

- Term: Exophthalmos

- ID: D000009916

- Term: Orbital Diseases

- ID: D000030342

- Term: Genetic Diseases, Inborn

- ID: D000006042

- Term: Goiter

- ID: D000006980

- Term: Hyperthyroidism

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M16718

- Name: Thyroid Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: HIGH

- As Found: Ophthalmopathy

- ID: M26148

- Name: Graves Ophthalmopathy

- Relevance: HIGH

- As Found: Graves Ophthalmopathy

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M18339

- Name: Eye Diseases, Hereditary

- Relevance: LOW

- As Found: Unknown

- ID: M9214

- Name: Graves Disease

- Relevance: LOW

- As Found: Unknown

- ID: M8237

- Name: Exophthalmos

- Relevance: LOW

- As Found: Unknown

- ID: M12845

- Name: Orbital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: M9147

- Name: Goiter

- Relevance: LOW

- As Found: Unknown

- ID: M10031

- Name: Hyperthyroidism

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005128

- Term: Eye Diseases

- ID: D000049970

- Term: Graves Ophthalmopathy

### Intervention Browse Module - Ancestors

- ID: D000000975

- Term: Antioxidants

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000020011

- Term: Protective Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000014131

- Term: Trace Elements

- ID: D000018977

- Term: Micronutrients

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M15455

- Name: Selenium

- Relevance: HIGH

- As Found: Repetitive Transcranial Magnetic Stimulation

- ID: M8618

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M17546

- Name: Vitamin B Complex

- Relevance: LOW

- As Found: Unknown

- ID: M4292

- Name: Antioxidants

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

- ID: T446

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T448

- Name: Folate

- Relevance: LOW

- As Found: Unknown

- ID: T475

- Name: Vitamin B9

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000012643

- Term: Selenium

### Misc Info Module

- Version Holder: 2024-05-31
