| - candidate number | 0 |
| - NTR Number | NTR87 |
| - ISRCTN | ISRCTN26633557 |
| - Date ISRCTN created | 12-sep-2005 |
| - date ISRCTN requested | 15-aug-2005 |
| - Date Registered NTR | 6-mei-2005 |
| - Secondary IDs | 04/072 MEC |
| - Public Title | Selenium supplementation in euthyroid patients with thyroid peroxidase antibodies. |
| - Scientific Title | Selenium supplementation in euthyroid patients with thyroid peroxidase antibodies. |
| - ACRONYM | N/A |
| - hypothesis | N/A |
| - Healt Condition(s) or Problem(s) studied | Euthyroidism, Thyroid peroxidase antibodies |
| - Inclusion criteria | Thyroid peroxidase antibodies >100 kU/l, TSH 0.4-4.0 mE/L, FT4 10-23 pmol/l, T3 1.30-2.70 nmol/L, female sex. |
| - Exclusion criteria | Use of multivitamin tablets containing selenium in the month preceding inclusion, drug or alcohol abuse, no informed consent. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-aug-2005 |
| - planned closingdate | 1-jan-2007 |
| - Target number of participants | 150 |
| - Interventions | Selenium supplementation or placebo. |
| - Primary outcome | Change of TPO-antibody concentration, difference in TSH level. |
| - Secondary outcome | Development of subclinical or overt hypothyroidism and quality of life estimation. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | MD. S.A. Eskes |
| - CONTACT for SCIENTIFIC QUERIES | Prof. Dr. W.M. Wiersinga |
| - Sponsor/Initiator | Academic Medical Center (AMC), Department of Internal Medicine |
| - Funding (Source(s) of Monetary or Material Support) | Academic Medical Center (AMC) |
| - Publications | N/A |
| - Brief summary | N/A |
| - Main changes (audit trail) | |
| - RECORD | 15-aug-2005 - 19-okt-2009 |
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