Selenium supplementation in euthyroid patients with thyroid peroxidase antibodies
| ISRCTN | ISRCTN26633557 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26633557 |
| Secondary identifying numbers | NTR87; MEC number: 04/072 |
- 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
Dr S.A. Eskes
Scientific
Scientific
Academic Medical Centre
Department of Endocrinology
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
Study information
| Study design | Randomised double blind, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | Euthyroidism |
| Intervention | Selenium supplementation or placebo |
| Intervention type | Other |
| Primary outcome measure | 1. Change of TPO-antibody concentration, 2. Difference in TSH level |
| Secondary outcome measures | 1. Development of subclinical or overt hypothyroidism 2. Quality of life estimation |
| Overall study start date | 01/08/2005 |
| Completion date | 31/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | 150 |
| Key inclusion criteria | 1. Thyroid peroxidase antibodies greater than 100 kU/l 2. Thyroid stimulating hormone (TSH) 0.4 - 4.0 mE/L 3. Free thyroxine (FT4) 10 - 23 pmol/l 4. Triiodothyronine (T3) 1.30 - 2.70 nmol/L 5. Female sex |
| Key exclusion criteria | 1. Use of multivitamin tablets containing selenium in the month preceding inclusion 2. Drug or alcohol abuse 3. No informed consent |
| Date of first enrolment | 01/08/2005 |
| Date of final enrolment | 31/07/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Internal Medicine
Meibergdreef 9
Amsterdam
1100 DD
Netherlands
"ROR" |
https://ror.org/03t4gr691 |
|---|
Funders
Funder type
Hospital/treatment centre
Academic Medical Centre (AMC) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
