Remission Induction and Sustenance in Graves' Disease 2

Not Applicable

Completed

• Conditions: Graves Disease; Hyperthyroidism
• Interventions: Other: Stop medication

• Registration Number: NCT00796913
• Lead Sponsor: Aalborg University Hospital

Brief Summary

ATD therapy for Graves' disease is one of the commonly used options for therapy of the hyperthyroidism. The investigators study how to optimally keep patients in remission.

Detailed Description

A detailed description of patients entering the initial observational phase of the study (RISG1) has been published:

Laurberg P, Nygaard B, Andersen S, Carlé A, Karmisholt J, Krejbjerg A, Pedersen IB, Andersen SL. Association between TSH-Receptor Autoimmunity, Hyperthyroidism, Goitre, and Orbitopathy in 208 Patients Included in the Remission Induction and Sustenance in Graves' Disease Study. J Thyroid Res. 2014;2014:165487. doi: 10.1155/2014/165487.

Study Timeline

• Study Start: 2008-01-07
• Study First Submitted: 2008-11-21
• Study First Submitted QC: 2008-11-21
• Study First Posted: 2008-11-24
• Primary Completion: 2015-05-15
• Study Completion: 2015-05-15
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

• Graves hyperthyroidism in remission after ATD

Exclusion Criteria

• Age < 18, severe concomitant disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stop of medication after remission	Stop medication	After enetering remission patients are randomised to continue low dose medication or to stop medication: Overview of study described in: Laurberg P, Nygaard B, Andersen S, Carlé A, Karmisholt J, Krejbjerg A, Pedersen IB, Andersen SL. Association between TSH-Receptor Autoimmunity, Hyperthyroidism, Goitre, and Orbitopathy in 208 Patients Included in the Remission Induction and Sustenance in Graves' Disease Study. J Thyroid Res. 2014;2014:165487. doi: 10.1155/2014/165487.
Se-yeast 200 Microgr/day + arm A	Stop medication	Additional arm where patients have been taking Se supplements during RISG1 therapy, and for 2 years after ATD withdrawal.

Primary Outcome Measures

Name	Time	Method
Relapse of hyperthyroidism	2 years

Secondary Outcome Measures

Name	Time	Method
Reoccurrence of TSH-receptor autoimmunity	2 years