Status:
UNKNOWN
Vitamin D in the Treatment of Primary Restless Legs Syndrome
Lead Sponsor:
King Abdulaziz University
Collaborating Sponsors:
King AbdulAziz City for Science and Technology
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
Restless Legs Syndrome (RLS) is a sensorimotor disorder that syndrome may substantially interfere with normal sleep, leading to significant impairment in patients' productivity and quality of life. T...
Eligibility Criteria
Inclusion
- Newly diagnosed or already diagnosed patients with primary RLS and vitamin D deficiency.
- Patients that are not currently receiving any treatment for RLS or vitamin D replacement therapy.
- Patients from 18 to 75 years old.
- Patients otherwise are in good general health.
Exclusion
- Patients diagnosed with secondary RLS. i.e.: patients with:
- 1\. Iron deficiency anemia 2. End-stage renal disease. 3. Diabetes mellitus (DM). 4. Peripheral neuropathy. 5. Multiple sclerosis (MS). 6. Pregnancy.
- 2\. Patients with other mimicking disorders or primary sleep disorders. E.g.:
- Arthritis.
- Deep venous thrombosis.
- Varicose veins or venous insufficiency.
- Habitual foot tapping.
- 3\. Patients receiving medications that can trigger RLS. i.e.:
- Anti hypertensive medications. E.g. Use of thiazide diuretics at a total dose greater than 37.5 mg/day.
- Anti convulsion medications.e.g. Use of anticonvulsant drug started within 6 months of screening. Stable regimen of anticonvulsants is allowed.
- Antinausea drugs (prochlorperazine or metoclopramide).
- Antipsychotic drugs (haloperidol or phenothiazine derivatives).
- Anti depressants (SSRIs).
- Antihistamines as in cold and allergy medications.
- 4\. Patients with current medications or conditions that would interfere with vitamin D absorption:
- 1\. Celiac disease. 2. Chron's disease. 3. Chronic pancreatitis. 4. Cystic fibrosis. 5. Weight-loss drug e.g. orlistat. 6. Cholesterol-lowering drug e.g. cholestyramine
- 5\. Patients with contraindications for vitamin D supplements. i.e.:
- Hyperparathyroidism.
- Kidney stones.
- Liver diseases.
- Granulomatous disorders (sarcoidosis, tuberculosis)
- 6\. Patients 17 years old and younger.
- 7\. Use of supplements containing vitamin D at total doses higher than 1000 IU/day within 12 weeks of the baseline visit initiating the protocol and unwillingness to limit vitamin D supplementation dosage to no higher than 1000 IU/day for the duration of the study.
- 8\. Use of supplements containing calcium at total doses higher than 600 mg/day within 1 week of the baseline visit initiating the protocol and unwillingness to limit calcium supplementation dosage to no more than 600 mg/day for the duration of the study.
- 9\. History of intolerance to vitamin D supplements.
- 10\. Women only: A. Pregnancy (past 1 year by report or positive pregnancy test at screening), intent to become pregnant in the next 4 years or unprotected intercourse. History of gestational diabetes is not an exclusion criterion.
- B. Currently breastfeeding. C. Use of oral contraceptives or menopausal hormone therapy started within 3 months of baseline. Stable regimen of oral contraceptives or any other hormonal method of contraception (e.g. implantable) is allowed.
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT02256215
Start Date
December 1 2015
Last Update
April 6 2015
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