Selenium supplementation in euthyroid patients with thyroid peroxidase antibodies
| ISRCTN | ISRCTN26633557 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26633557 |
| Protocol serial number | NTR87; MEC number: 04/072 |
| 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
Dr S.A. Eskes
Scientific
Scientific
Academic Medical Centre
Department of Endocrinology
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind, active 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 | Euthyroidism |
| Intervention | Selenium supplementation or placebo |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Change of TPO-antibody concentration, |
| Key secondary outcome measure(s) |
1. Development of subclinical or overt hypothyroidism |
| Completion date | 31/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
