Treatment of patients with amiodarone-induced thyrotoxicosis type 2
| ISRCTN | ISRCTN06558177 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06558177 |
| Protocol serial number | NTR78; MEC number: 03/271 |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Funder | Academic Medical Centre (AMC) (Netherlands) |
- Submission date
- 12/09/2005
- Registration date
- 12/09/2005
- Last edited
- 03/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof W.M. Wiersinga
Scientific
Scientific
Academic Medical Center
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, single blind, placebo controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Amiodarone-induced thyrotoxicosis type 2 |
| Intervention | Treatment with: 1. Methimazole and prednisone 2. Methimazole and sodium perchlorate 3. Methimazole, sodium perchlorate and prednisone |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Methimazole, prednisone, sodium perchlorate |
| Primary outcome measure(s) |
Achievement of euthyroidism (TSH greater than 0.4 mE/L at 3 and 6 months). |
| Key secondary outcome measure(s) |
Development side-effects. |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 45 |
| Key inclusion criteria | 1. Thyroid stimulating hormone (TSH) less than 0.4 mE/L 2. Free thyroxine (FT4) greater than 25 pmol/l 3. Normal or raised triiodothyronine (T3) 4. Thyroid peroxidase antibodies less than 50 kU/l 5. Thyroid binding inhibitory immunoglobulins (TBII) less than 2.0 kU/l 6. Amiodarone use 7. Poor or no visualisation of thyroid gland on 99mTc-pertechnetate scintigraphy 8. No nodular goiter on ultrasound |
| Key exclusion criteria | 1. Very critical illness 2. Drug or alcohol abuse 3. Pregnancy 4. No informed consent |
| Date of first enrolment | 01/03/2004 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
