Neuropsychologic and Immunological Evaluation in Treatment of Thyroid Diseases. Is Selenium Efficient?
1 other identifier
interventional
44
1 country
2
Brief Summary
Graves thyrotoxicosis is a common autoimmune disease. Patients suffer at diagnosis from weight loss, increased heart rate and stress intolerance. Some patients have difficulties in regaining quality of life. Diagnosis is found through elevated thyroid hormones thyroxin, suppressed TSH (thyroid stimulating hormone) from the pituitary and elevated stimulatory antibodies, TRAb (thyrotropin receptor antibody) to the thyroid. Selenium is sparse in western Europe. This compound has important function in thyroid hormone metabolism and on the immune system. It is not known whether addition of selenium affects the well being of patients with Graves´thyrotoxicosis. The subject of this study is to investigate this
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2008
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 23, 2010
CompletedFirst Posted
Study publicly available on registry
November 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedMarch 31, 2015
March 1, 2015
5.3 years
November 23, 2010
March 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect on neuropsychological well-being
Inclusion going on until the end of 2011
Secondary Outcomes (1)
Potential effect on autoantibodies
Inclusion for the rest of 2011
Study Arms (2)
placebo
ACTIVE COMPARATORPlacebo and thyroxin + methimazole
selenium
PLACEBO COMPARATORselenium + methimazole + thyroxin
Interventions
Eligibility Criteria
You may qualify if:
- New diagnose of autoimmune thyrotoxicosis
- biochemically proven with increased thyroxin
- low TSH and elevated TRAb/or positive scintigraphy.
- Age 18 - 55. Willing to participate -
You may not qualify if:
- No previous head trauma,
- No difficulties with swedish language,
- No medication which could affective neuropsychological testing,
- No planned or ongoing pregnancies.
- Normal intellectual capacity.
- No severe ophthalmopathy, or other severe disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Jan Calissendorff, Medical clinic, Eskilstuna, Sweden
Eskilstuna, Södermanland County, 63188, Sweden
Emil Mikulski
Eskilstuna, 63188, Sweden
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Calissendorff, MD, PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior consultant
Study Record Dates
First Submitted
November 23, 2010
First Posted
November 24, 2010
Study Start
November 1, 2008
Primary Completion
March 1, 2014
Study Completion
April 1, 2014
Last Updated
March 31, 2015
Record last verified: 2015-03