A comparison of intravenous iron and placebo (NaCl) for treatment of Restless Legs Syndrome (RLS)

A randomised, double-blind, comparative, multi-centre study of intravenous iron and placebo (NaCl) for treatment of Restless Legs Syndrome (RLS)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN82469428

Enrollment

Registered

2008-02-15

Start date

2003-06-26

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless legs syndrome Nervous System Diseases Restless legs syndrome

Interventions

200 mg iron sucrose intravenously 5 times over 3 weeks versus placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years 2. RLS defined by four cardinal criteria 3. Ten points or more on the International RLS (IRLS) Study Group Rating Scale 4. S-ferritin below 45 µg/L, and with folic acid and vitamin B12 within reference values 5. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. Treatment with any of the following: 1.1. Psychopharmacological treatment with antidepressive and dopaminergic agents, sedatives, anticonvulsants and/or pain relievers, i.e. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or stronger, during the preceding 2 weeks. This was changed in study protocol clarification number 2 to "...i.e. with the exception of NSAIDs - during the last 2 weeks". 1.2. Calcium antagonists, antihistaminic or antiemetic drugs during the preceding 2 weeks. 1.3. Iron administration during the preceding 2 months 1.4. Nutritional supplements or natural pharmaceuticals containing iron 1.5. Antiepileptics 1.6. Vitamin B12 or folic acid 2. Presence of clinically significant disease/dysfunction, which in the opinion of the investigator should disqualify the patient from this study, such as asymptomatic intestinal bleeding 3. Patients suffering from obstructive sleep apnoea syndrome 4. S-creatinine >130 µmol/L 5. Positive result of pregnancy test 6. Breast-feeding women 7. Contraindications for iron sucrose

Design outcomes

Primary

Measure	Time frame
International RLS Study Group Rating Scale at 11 weeks	—

Secondary

Measure	Time frame
1. Epworth Sleepiness Scale at baseline, after 3 , 7 and 11 weeks, 5 , 8 and 12 months 2. Incidences and severities of adverse events, assessed after 3 , 7 and 11 weeks, 5, 8 and 12 months 3. To assess the ability of the treatments to correct aberrant haematology and iron status at baseline, after 3 , 7 and 11 weeks, 5 , 8 and 12 months	—

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026