HyperthyroidismNCT00525122
Treatment of M.Graves With Radioactive Iodine: Follow-up Study
An observational study of Hyperthyroidism, run by Medisch Centrum Rijnmond-Zuid, Netherlands at 1 site in Netherlands.
Trial summary
Hypothesis: What is the natural course after treatment with radioactive iodine in patients with hyperthyroidism? What are the determinants for the development of acute hypo- or hyperthyroidism after treatment with radioactive iodine without antithyroid drugs? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperthyroidism
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2007to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of 18 years and older with hyperthyroidism who are eligible for treatment with radioactive iodine.
Who may be able to join
- Patients wth hyperthyroidism who are eligible for treatment with radioactive iodine
- Age > 18 years
Who cannot join
- Severe ophthalmopathy
- Pregnancy or wish to pregnancy on short term
- Breastfeeding
- Patients already treated with radioactive iodine
- Known cardiovascular diseases or other severe comorbidity
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
MCRZ
Rotterdam, South Holland, 3075 EA
A Berghout, MD, PhD
About this study
Hypothesis: What is the natural course after treatment with radioactive iodine in patients with hyperthyroidism?
What are the determinants for the development of acute hypo- or hyperthyroidism after treatment with radioactive iodine without antithyroid drugs?
- Conditions
- Hyperthyroidism
- Keywords
- hyperthyroidism, radioactive iodine, antithyroid drugs, Hyperthyroidism, treatment with radioactive iodine without antithyroid drugs
- Medical subject headings
- Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with hyperthyroidism who are will be treated with radioactive iodine. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medisch Centrum Rijnmond-Zuid, Netherlands
- Sponsor type
- Other government
- Investigators
- A. Berghout, MD, PhD, Principal investigator, Medisch Centrum Rijnmond-Zuid, NetherlandsC. van Noord, MD, Principal investigator, Medisch Centrum Rijnmond-Zuid, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525122
- Sponsor's protocol ID
- 2006/60
- Status last verified
- May 2008
- First submitted
- 4 Sep 2007
- Last updated
- 22 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of M.Graves With Radioactive Iodine: Follow-up Study
- ClinicalTrials.gov ID
- NCT00525122
- Acronym / sponsor ID
- 2006/60
- Conditions
- Hyperthyroidism
- Keywords
- hyperthyroidism, radioactive iodine, antithyroid drugs, Hyperthyroidism, treatment with radioactive iodine without antithyroid drugs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medisch Centrum Rijnmond-Zuid, NetherlandsOther government
- Study start
- Sep 2007
- First posted
- 5 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: What is the natural course after treatment with radioactive iodine in patients with hyperthyroidism?
What are the determinants for the development of acute hypo- or hyperthyroidism after treatment with radioactive iodine without antithyroid drugs?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with hyperthyroidism who are will be treated with radioactive iodine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of 18 years and older with hyperthyroidism who are eligible for treatment with radioactive iodine.
Key inclusion criteria (2 listed)
- Patients wth hyperthyroidism who are eligible for treatment with radioactive iodine
- Age > 18 years
Key exclusion criteria (5 listed)
- Severe ophthalmopathy
- Pregnancy or wish to pregnancy on short term
- Breastfeeding
- Patients already treated with radioactive iodine
- Known cardiovascular diseases or other severe comorbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2008.
Related trials for Hyperthyroidism
Not yet recruiting
Impact of Restrictive Diets on Inflammation and Quality of Life in Autoimmune Thyroiditis
Thyroid Autoimmune Disease, Hashimoto's Thyroiditis
RecruitingPhase 3
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease
Graves' Disease, Graves Disease
RecruitingPhase 3
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.
Graves Disease
Active, not recruitingPhase 4
Hydroxychloroquine in Mild Graves' Orbitopathy
Graves Ophthalmopathy
RecruitingPhase 2
A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
Graves' Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A. Berghout, MD, PhD principal investigator
Medisch Centrum Rijnmond-Zuid, Netherlands
C. van Noord, MD principal investigator
Medisch Centrum Rijnmond-Zuid, Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperthyroidism, run by Medisch Centrum Rijnmond-Zuid, Netherlands at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact A. Berghout, MD, PhD (0031 10 2913368, BerghoutA@mcrz.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2008.