Restless Legs Syndrome
Conditions
Interventions
Nonanemiac iron deficiency RLS group (RLS-IDNA):Ferrous succinate 0.1g bid combined with vitamin C 100mg bid po for 12 weeks
iron deficiency anemia RLS group (RLS-IDA):Ferrous succinate 0.1g bid combined with vitamin C 100mg bid po for 12 weeks
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Non anemiac iron deficiency RLS group (RLS-IDNA): 1) The included patients should meet the 2014 diagnostic criteria of international RLS study group (IRLSSG). 2) Aged >=18 years, male or female. 3) Chinese Han population. 4) No iron supplymentary theray has been ever recieved in the included patients. 5) The included patients have not taken dopaminergic drugs or a - 2 - d ligand drugs (or stopped using dopaminergic drugs or a-2-dligand drugs for at least 2 weeks). 6) Without anemia (the hemoglobin levels >= 113g / L in female, and the hemoglobin levels >= 131g / L in male). 7) With peripheral iron deficiency (serum ferritin levels = 75 µ g / L but TSAT < 20%). 8) The patients should experience at least two RLS episodes in the past week at the time of the screening interview. 9) Patients signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Non anemiac iron deficiency RLS group (RLS-IDNA): 1) Secondary RLS patients: such as iron deficiency anemia, end-stage renal disease, pregnancy, peripheral neuropathy and Parkinson's disease. 2) Subjects with drug abuse, alcoholism or long-term use of psychotropic drugs that may cause endogenous restlessness. 3) Subjects with cognitive impairment (MMSE <= 24) or unable to cooperate with the scale score. 4) Pregnant women. 5) There are no oral iron supplement contraindications. 6) Patients with severe co-morbidities. 7) Those who are not willing to participate in the study or cannot sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood alpha-synuclein system;serum iron parameters;MRI QSM signals in SN; | — |
Secondary
| Measure | Time frame |
|---|---|
| severity of RLS (IRLSRS);PLMS;severity of RLS (RLS-6);CGI; | — |
Countries
China
Contacts
Public ContactXiaoying Zhu
Shanghai General Hospital
Outcome results
None listed