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the main research is no longer in the Institution
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Restless leg syndrome (RLS) is sleep disorder characterized by an unpleasant feeling in the lower limbs, which can be accompanied by paresthesias, and need for urgent movement of the legs. Its diagnosis is clinical, based on an International Committee of the Study of RLS (International Restless Legs Syndrome Study) questionnaire. Its prevalence is about 5-15% in the general population, being twice as frequent in women and with a tendency to increase incidence with aging. In the chronic kidney disease (CKD) population, mainly in patients on dialysis, the prevalence increases by up to 70%. Vitamin D deficiency is associated with RLS and active vitamin D supplementation seems to improve RLS and severity. It is seems, studies on the role of vitamin D supplementation in CKD population are missing. The clinical-scientific hypothesis of this study is that replacement of vitamin D (cholecalciferol) will improve the symptoms of RLS. As parathyroidectomy can relieve RLS, the aim of researchers is to randomize patients with CKD on dialysis to receive cholecalciferol or placebo in 2 distinct groups: secondary hyperparathyroidism and adynamic bone disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperparathyroidism_0 | Placebo Comparator | Chronic Kidney Disease patients with parathyroid hormone higher than 300pg/ml |
|
| Hyperparathyroidism_1 | Active Comparator | Chronic Kidney Disease patients with parathyroid hormone higher than 300pg/ml |
|
| Adynamic_0 | Placebo Comparator | Chronic Kidney Disease patients with parathyroid hormone lower than 150pg/ml |
|
| Adynamic_1 | Active Comparator | Chronic Kidney Disease patients with parathyroid hormone lower than 150pg/ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | patients will receive vitamin D supplementation according to guidelines |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement RLS severity | Reduction of the disease's symptoms | 6 months |
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Inclusion Criteria
- adult patients with chronic kidney disease on dialysis, with vitamin D deficiency.
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clinicas | São Paulo | São Paulo | 05403-000 | Brazil |
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| Placebo Oral Tablet | Drug | patients will receive placebo oral tablets |
|
| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| D007676 | Kidney Failure, Chronic |
| D006962 | Hyperparathyroidism, Secondary |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| D001523 | Mental Disorders |
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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