Prospective analysis of the therapeutic efficacy of iron isomaltoside in combination with or without dopaminergic therapy in patients with restless legs syndrome

Conditions

restless leg syndrome

Brief summary

Changes in RLS severity as detected by the IRLS

Detailed description

Changes in RLS severity as detected by the sIRLS, RLS-6 and CGI, Changes in blood count, iron, Tf, TSAT, ferritin, sTfR, hepcidin-25, creatinine (GFR), GPT, GOT, LDH, CRP, electrolytes (Na, K, P, Ca), PTH, LCN2, dopamine, 1,25-(OH)2 vitamin D, 25-OH vitamin D, EPO, ERFE, PDGF-BB, LCN2 and metabolites (ATP, NADH/NAD, Lactate, Succinate, Citrate, Pyruvate, free fatty acids), Changes in mitochondrial iron and Krebs cycle metabolism gene expression in monocytes detected by RT-PCR, Changes in mitochondrial respiration of selected and randomly assigned patients measured with OROBOROS respirometry, Changes in iron content in the substantia nigra detected by an MRI in a subgroup of 80 patients (20 dopaminergic therapy/iron, 20 dopaminergic therapy/placebo, 20 no previous treatment/iron and 20 no previous treatment/placebo)

Related papers

No related papers found yet.

Interventions

DRUGMonoFer 100 mg/ml Lösung zur Injektion/Infusion

DRUGKochsalz ”Braun” 0

DRUG9% - Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Changes in RLS severity as detected by the IRLS	—

Secondary

Measure	Time frame
Changes in RLS severity as detected by the sIRLS, RLS-6 and CGI, Changes in blood count, iron, Tf, TSAT, ferritin, sTfR, hepcidin-25, creatinine (GFR), GPT, GOT, LDH, CRP, electrolytes (Na, K, P, Ca), PTH, LCN2, dopamine, 1,25-(OH)2 vitamin D, 25-OH vitamin D, EPO, ERFE, PDGF-BB, LCN2 and metabolites (ATP, NADH/NAD, Lactate, Succinate, Citrate, Pyruvate, free fatty acids), Changes in mitochondrial iron and Krebs cycle metabolism gene expression in monocytes detected by RT-PCR, Changes in mitochondrial respiration of selected and randomly assigned patients measured with OROBOROS respirometry, Changes in iron content in the substantia nigra detected by an MRI in a subgroup of 80 patients (20 dopaminergic therapy/iron, 20 dopaminergic therapy/placebo, 20 no previous treatment/iron and 20 no previous treatment/placebo)	—

Measure

Time frame

Changes in RLS severity as detected by the sIRLS, RLS-6 and CGI, Changes in blood count, iron, Tf, TSAT, ferritin, sTfR, hepcidin-25, creatinine (GFR), GPT, GOT, LDH, CRP, electrolytes (Na, K, P, Ca), PTH, LCN2, dopamine, 1,25-(OH)2 vitamin D, 25-OH vitamin D, EPO, ERFE, PDGF-BB, LCN2 and metabolites (ATP, NADH/NAD, Lactate, Succinate, Citrate, Pyruvate, free fatty acids), Changes in mitochondrial iron and Krebs cycle metabolism gene expression in monocytes detected by RT-PCR, Changes in mitochondrial respiration of selected and randomly assigned patients measured with OROBOROS respirometry, Changes in iron content in the substantia nigra detected by an MRI in a subgroup of 80 patients (20 dopaminergic therapy/iron, 20 dopaminergic therapy/placebo, 20 no previous treatment/iron and 20 no previous treatment/placebo)

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Countries

Austria

Outcome results

None listed