Trials / Withdrawn
WithdrawnNCT03063190
Cholecalciferol Supplementation in Restless Leg Syndrome in Patients With Chronic Kidney Disease
Evaluation of Cholecalciferol Supplementation in Chronic Kidney Disease Patients With Restless Leg Syndrome
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Sao Paulo General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Restless Leg Disorder
- Renal Disease Bone
- Renal Disease, End Stage
- Hyperparathyroidism, Secondary
- Adynamic Bone Disease
- Vitamin D Deficiency
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vitamin D | patients will receive vitamin D supplementation according to guidelines |
| DRUG | Placebo Oral Tablet | patients will receive placebo oral tablets |
Timeline
- Start date
- 2022-03-31
- Primary completion
- 2022-03-31
- Completion
- 2023-03-01
- First posted
- 2017-02-24
- Last updated
- 2021-09-30
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT03063190. Inclusion in this directory is not an endorsement.