Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole
Randomized Open Clinical Study to Evaluate the Efficacy of Selenium Plus Methimazole for Treatment of Graves' Hyperthyroidism
1 other identifier
interventional
30
1 country
1
Brief Summary
Evaluation of the efficacy of the combined treatment (methimazole plus selenium) in the control of hyperthyroidism as compared to methimazole alone in 30 Graves' disease (GD) untreated patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 5, 2016
CompletedApril 6, 2016
April 1, 2016
1.7 years
June 30, 2015
April 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Control of hyperthyroidism
Comparison of FT3 and FT4 values (pg/ml) between groups
90 days
Clinical manifestations of hyperthyroidism-1
Comparison of heart rate between groups
90 days
Clinical manifestations of hyperthyroidism-2
Comparison of BMI between groups
90 days
Clinical manifestations of hyperthyroidism-3
Comparison of total serum cholesterol between groups
90 days
Clinical manifestations of hyperthyroidism-4
Comparison of total serum sex hormone binding globulin between groups
90 days
Clinical manifestations of hyperthyroidism-5
Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups
90 days
Secondary Outcomes (17)
Control of hyperthyroidism
45 days
Clinical manifestations of hyperthyroidism-1
45 days
Selenium levels
45 days
Selenium levels
90 days
Oxidative stress parameters-1
45 days
- +12 more secondary outcomes
Study Arms (2)
Methimazole plus selenium
EXPERIMENTALMethimazole 5-30 mg daily for 90 days Selenium 80 bid for 90 days
Methimazole
ACTIVE COMPARATORMethimazole 5-30 mg daily for 90 days
Interventions
Selenium 80 mg bid for 90 days
Methimazole starting dose depending on FT3 values (15 mg/day or 20 mg/day or 30 mg/day, for FT3 values \<10 pg/ml, 10-15 pg/ml, \>15 pg/ml, respectively) to be tapered by 5 mg/day every 15 days down to values sufficient for FT3 to be normal
Eligibility Criteria
You may qualify if:
- Hyperthyroid untreated Graves' disease patients
You may not qualify if:
- Hyperthyroid treated Graves' disease patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Endocrinology Unit
Pisa, PI, 56124, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudio Marcocci, MD
Department of Clinical and Experimental Medicine, University of Pisa
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
- MD
Study Record Dates
First Submitted
June 30, 2015
First Posted
April 5, 2016
Study Start
January 1, 2014
Primary Completion
September 1, 2015
Study Completion
December 1, 2015
Last Updated
April 6, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share