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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-23 | Other Identifier | AP HM |
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The aim of our study is to compare in a randomized multicentric study the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation (experimental arm) compared to a conventional approach based on the initiation of LT4 as soon as the first biological signs of hypothyroidism. Two hundred patients with Graves' disease with no or minimal (eyelid retraction or oculopalpebral asynergy) and non inflammatory ophthalmopathy (clinical activity score to 0) will be included in this study. The administrated iodine-131 activity will be adjusted to the weight of the thyroid gland (20 MBq/g thyroid tissue). Patients will be evaluated at 6 weeks, 3 months, 6 months and 12 months post-ablation. The primary objective will assess differences in terms of quality of life at 3 months using a specific questionnaire (ThyPRO). Secondary objectives will compare quality of life outcomes at different study visits (using ThyPRO and SF36), fatigue (MFIS) and depression (Beck), autoimmune parameters (signs of ophthalmopathy, TSH receptor antibodies assessment), efficacy and medico-economic data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional approach | Other | conventional traitment |
|
| experimental approach | Experimental | early and systematic traitment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation | Drug |
| ||
| The initiation of LT4 as soon as the first biological signs of hypothyroidism. |
| Measure | Description | Time Frame |
|---|---|---|
| will assess differences in terms of quality of life at 3 months using a specific questionnaire (ThyPRO). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| compare quality of life outcomes at different study visits (using ThyPRO and SF36), fatigue (MFIS) and depression (Beck), autoimmune parameters (signs of ophthalmopathy, TSH receptor antibodies assessment), efficacy and medico-economic data. | 2 years |
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Inclusion Criteria:
Patient presenting a hyperthyroïdie Basedowienne proving a treatment by iodine 131.
Exclusion Criteria:
Patient presenting a thyroïdien nodule suspect of wickedness.
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| Name | Affiliation | Role |
|---|---|---|
| BERNARD BELAIGUES | Assistance Publique hôpitaux de Marseille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille | Marseille | 13354 | France |
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| Drug |
|
| ID | Term |
|---|---|
| D006111 | Graves Disease |
| ID | Term |
|---|---|
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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