Restless Legs Syndrome. Restless legs syndrome
Conditions
Interventions
Intervention 1: Intervention group: Daily administration of 20 mg elemental iron as Irofix iron syrup (manufacturing license holder: Omid Darou Salamat Company, under license of Dayonix Pharma) plus 9
Sponsors
Qazvin University of Medical Sciences
Eligibility
Sex/Gender
All
Age
4 Years to 12 Years
Inclusion criteria
Inclusion criteria: Children aged 4 to 12 years Diagnosis of Restless Legs Syndrome based on IRLSSG clinical diagnostic criteria Written informed consent obtained from parents for participation in the study
Exclusion criteria
Exclusion criteria: Presence of underlying diseases such as renal failure Lack of cooperation from the child or parents during the study Use of iron or magnesium supplements during the past month Serum ferritin level less than 50 ng/mL Lack of cooperation from the child or parents during the study Vitamin D deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms of Restless Legs Syndrome in children. Timepoint: At baseline (before the start of the intervention) and at the end of the fourth week after initiation of the intervention. Method of measurement: Restless Legs Syndrome Severity Questionnaire for Children. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep quality in children. Timepoint: At baseline (before the start of the intervention) and at the end of the fourth week after initiation of the intervention. Method of measurement: Brief Infant Sleep Questionnaire.;Sleep duration in children. Timepoint: At baseline (before the start of the intervention) and at the end of the fourth week after initiation of the intervention. Method of measurement: Brief Infant Sleep Questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactKhatereh Khamenehpour
Qazvin University of Medical Sciences
Outcome results
None listed