Selenium Supplementation Versus Placebo in Patients With Graves' Hyperthyroidism (GRASS)
This study is currently recruiting participants.
Verified January 2013 by Rigshospitalet, Denmark
Sponsor:
Rigshospitalet, Denmark
Collaborators:
Odense University Hospital
Hospital of South West Denmark
Herlev Hospital
Bispebjerg Hospital
Hvidovre Hospital
Hillerød Hospital
Copenhagen Trial Unit, Center for Clinical Intervention Research
The Danish Council for Independent Research - Medical Sciences
The Danish Council for Strategic Research
Information provided by (Responsible Party):
Per Cramon, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01611896
First received: May 29, 2012
Last updated: January 25, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to investigate if selenium supplementation to the standard treatment with anti-thyroid drugs in patients with Graves' hyperthyroidism, will lead to a fewer people with anti-thyroid treatment failure and faster remission, in terms of better quality of life during the first year of treatment and more patients staying in remission.
| Condition | Intervention |
|---|---|
|
Graves' Hyperthyroidism |
Dietary Supplement: Selenium Other: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | GRAves Selenium Supplementation Trial (GRASS) - an Investigator-initiated Randomised, Blinded, Multicentre Clinical Trial of Selenium Supplementation Versus Placebo in Patients With Graves' Hyperthyroidism |
Resource links provided by NLM:
MedlinePlus related topics:
Thyroid Diseases
Drug Information available for:
Selenomethionine
U.S. FDA Resources
Further study details as provided by Rigshospitalet, Denmark:
Primary Outcome Measures:
- Proportion of participants with the composite outcome of 'ATD treatment failure' [ Time Frame: Last 12 months (± 1 month) of the intervention period ] [ Designated as safety issue: No ]
'ATD treatment failure' is defined as:
- The participant receives ATD treatment (at any level) during the last 12 months (± 1 month) of the intervention period; or
- The participant has thyroid hyperfunction (TSH <0.1) during the last 12 months (± 1 month) of the intervention period; or
- The participant has been referred to ablative therapy (radioactive iodine or thyroid surgery) at some point during the entire intervention period.
Secondary Outcome Measures:
- Proportion of participants who receives ATD treatment (at any level) during the last 12 months (± 1 month) of the intervention period [ Time Frame: Last 12 months (± 1 month) of the intervention period ] [ Designated as safety issue: No ]
- Proportion of participants who has thyroid hyperfunction (TSH <0.1) during the last 12 months (± 1 month) of the intervention period [ Time Frame: Last 12 months (± 1 month) of the intervention period ] [ Designated as safety issue: No ]
- Proportion of participants who has been referred to ablative therapy (radioactive iodine or thyroid surgery) at some point during the entire intervention period [ Time Frame: Intervention period (24-30 months) ] [ Designated as safety issue: No ]
- Thyroid-specific QoL during the first year after randomisation, and at the end of the intervention period (24-30 months), as measured by the global score in the ThyPRO questionnaire [ Time Frame: First year after randomisation, and at the end of the intervention period (24-30 months) ] [ Designated as safety issue: No ]
- Level of TRAb at 18 months, and at the end of the intervention period (24-30 months) [ Time Frame: 18 months, and at the end of the intervention period (24-30 months) ] [ Designated as safety issue: No ]
- Hyperthyroid symptoms (ThyPRO subscale) during first year after randomisation [ Time Frame: First year after randomisation ] [ Designated as safety issue: No ]
- Eye symptoms (ThyPRO subscale) during first year after randomisation, and at end of the intervention period (24-30 months) [ Time Frame: First year after randomisation, and at end of the intervention period (24-30 months) ] [ Designated as safety issue: No ]
- Number of participants with adverse reactions during the intervention period [ Time Frame: Intervention period (24-30 months) ] [ Designated as safety issue: No ]Participants will be asked to report about known adverse reactions (specified in the protocol) at 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, and 12 months after ATD treatment withdrawal. In addition, participants are instructed to contact their trial contact person in case they experience adverse reactions.
- Number of participants with serious adverse events during the intervention period [ Time Frame: Intervention period (24-30 months) ] [ Designated as safety issue: No ]
To make sure we get information on serious adverse events, data on hospital admissions and mortality will be obtained through the national databases (the National Patient Registry and the Danish Civil Registration System) at the end of the trial. Also, participants are informed and instructed to contact their trial contact person in case they:
- are admitted to a hospital for selenium intoxication;
- experience a clinical picture indicative of selenium intoxication; or
- experience a clinical picture unexpected, but suspected to be related to selenium intoxication.
| Estimated Enrollment: | 492 |
| Study Start Date: | October 2012 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Selenium |
Dietary Supplement: Selenium
100 µg tablets. The dose of daily supplement of selenium is set at 200 µg (two tablets). The duration of the intervention period is between 24-30 months. This is defined by the time of ATD treatment withdrawal, which is scheduled between approximately 12-18 months after randomisation. Selenium supplementation will continue 12 months after withdrawal of ATD treatment.
Other Name: 'Selen, organisk selen', produced by Jemo-Pharm A/S
|
| Placebo Comparator: Placebo |
Other: Placebo
Placebo tablets, identical in regards to size, appearance, taste, smell, and solubility to the experimental intervention tablet will be produced by Jemo-Pharm A/S, http://www.jemo-pharm.dk/frame.cfm/cms/id=977/sprog=2/grp=6/menu=1/ (content as in section: Auxiliary agents). The placebo regimen will be identical to the selenium regimen, but consist of two non-active tablets per day for 24-30 months.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18 years or older.
- Active Graves' hyperthyroidism (suppressed TSH (< 0.1) and positive TRAb) measured within the last two months prior to the inclusion date.
- Written informed consent
Exclusion Criteria:
- Major co-morbidity, making the participants unlikely to continuously receive trial intervention in the intervention period.
- Previous treatment with radioactive iodine.
- Current ATD treatment having been received for more than two months.
- Treatment with immunomodulatory drugs, such as cyclosporine A, methotrexate, cyclophosphamide.
- Allergy towards the components in the selenium and placebo pills.
- Pregnant or breast-feeding women.
- Intake of selenium supplementation above 70 µg per day (70 µg corresponds to the amount in a multivitamin tablet).
- Unable to read and understand Danish.
- Lack of informed consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611896
Contacts
| Contact: Per Cramon, MD | (+45) 51 68 45 33 | per.cramon@rh.regionh.dk |
| Contact: Torquil Watt, Ph.D. | (+45) 35 45 10 97 | torquil.watt@rh.regionh.dk |
Locations
| Denmark | |
| Department of Medical Endocrinology, Rigshospitalet | Recruiting |
| Copenhagen, Denmark | |
| Principal Investigator: Per Cramon, MD | |
| Sub-Investigator: Ulla Feldt-Rasmussen, DMSc | |
| Sub-Investigator: Torquil Watt, Ph.D. | |
| Sub-Investigator: Aase K Rasmussen, DMSc | |
| Department of Endocrinology and Gastroenterology, Bispebjerg Hospital | Not yet recruiting |
| Copenhagen, Denmark | |
| Principal Investigator: Nils Knudsen, Ph.D., DMSc | |
| Department of Endocrinology, Hospital of Southwest Denmark | Recruiting |
| Esbjerg, Denmark | |
| Principal Investigator: Jeppe Gram, Ph.D. | |
| Department of Internal Medicine O 106, Endocrine Unit, Herlev Hospital | Not yet recruiting |
| Herlev, Denmark | |
| Principal Investigator: Birte Nygaard, Ph.D. | |
| Department of Cardiology and Endocrinology, Endocrine Unit, Hillerød Hospital | Not yet recruiting |
| Hillerød, Denmark | |
| Principal Investigator: Runa Nolsøe, Ph.D. | |
| Department of Endocrinology, Section 541, Hvidovre Hospital | Not yet recruiting |
| Hvidovre, Denmark | |
| Principal Investigator: Pernille Bach-Mortensen, Ph.D. | |
| Department of Endocrinology and Metabolism, Odense University Hospital | Not yet recruiting |
| Odense, Denmark | |
| Principal Investigator: Steen J Bonnema, Ph.D. | |
| Sub-Investigator: Laszlo Hegedüs, DMSc | |
Sponsors and Collaborators
Rigshospitalet, Denmark
Odense University Hospital
Hospital of South West Denmark
Herlev Hospital
Bispebjerg Hospital
Hvidovre Hospital
Hillerød Hospital
Copenhagen Trial Unit, Center for Clinical Intervention Research
The Danish Council for Independent Research - Medical Sciences
The Danish Council for Strategic Research
Investigators
| Study Chair: | Aase K Rasmussen, DMSc | Department of Medical Endocrinology, Rigshospitalet |
| Study Chair: | Torquil Watt, Ph.D. | Department of Medical Endocrinology, Rigshospitalet |
| Study Chair: | Laszlo Hegedüs, DMSc | Department of Endocrinology and Metabolism, Odense University Hospital |
| Study Chair: | Steen J Bonnema, Ph.D. | Department of Endocrinology and Metabolism, Odense University Hospital |
| Study Chair: | Jeppe Gram, Ph.D. | Department of Endocrinology, Hospital of Southwest Denmark |
| Study Chair: | Christian Gluud, DMSc | Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet |
| Study Chair: | Jakob B Bjorner, Ph.D. | National Research Centre for the Working Environment, and Institue of Public Health Science, University of Copenhagen |
| Principal Investigator: | Per Cramon, MD | Department of Medical Endocrinology, Rigshospitalet |
More Information
No publications provided
| Responsible Party: | Per Cramon, Principal Investigator, Rigshospitalet, Denmark |
| ClinicalTrials.gov Identifier: | NCT01611896 History of Changes |
| Other Study ID Numbers: | H-4-2012-026, GRASS-DP-240, 2007-58-0015, 30-0770, H-4-2012-026 |
| Study First Received: | May 29, 2012 |
| Last Updated: | January 25, 2013 |
| Health Authority: | Denmark: Regional Research Ethical Committee for the Capital Region Denmark: Danish Dataprotection Agency |
Keywords provided by Rigshospitalet, Denmark:
|
Graves' hyperthyroidism Graves' disease Selenium |
Quality of Life ThyPRO Autoimmunity |
Additional relevant MeSH terms:
|
Selenium Hyperthyroidism Graves Disease Thyroid Diseases Endocrine System Diseases Exophthalmos Orbital Diseases Eye Diseases Goiter Autoimmune Diseases |
Immune System Diseases Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013