ferric-carboxymaltose and Sleep-Wake-Disorders

Prospective, randomized, controlled, single-centre trial. (ClinicalTrials.gov: NCT01787526).. Tertiary care center in Graz, Austria.. 176 (138 female and 38 male) whole-blood and platelet apheresis donors aged ≥ 18 and ≤ 65 years with iron deficiency (ferritin ≤ 30ng/mL at the time of blood donation).. Intravenous iron (1 g ferric carboxymaltose, n = 86) or oral iron supplementation (10 g iron fumarate, 100 capsules, n = 90).. Clinical symptoms were evaluated by a survey before iron therapy (visit 0, V0) and after 8-12 weeks (visit 1, V1), including questions about symptoms of restless legs syndrome (RLS), chronic fatigue syndrome (CFS), sleeping disorders, quality of life and symptoms like headaches, dyspnoea, dizziness, palpitations, pica and trophic changes in fingernails or hair.. We found a significant improvement in the severity of symptoms for RLS, fatigue and sleep quality (. Iron supplementation in iron-deficient blood donors may be an effective strategy to improve symptoms related to iron deficiency and the wellbeing of blood donors.

Topics: Administration, Oral; Adolescent; Adult; Aged; Anemia, Iron-Deficiency; Blood Donors; Dietary Supplements; Fatigue Syndrome, Chronic; Female; Ferric Compounds; Humans; Infusions, Intravenous; Iron, Dietary; Male; Maltose; Middle Aged; Quality of Life; Restless Legs Syndrome; Severity of Illness Index; Sleep Wake Disorders; Treatment Outcome; Young Adult

Restless sleep disorder has been described in the literature as a disorder affecting children and presenting with large muscle movements during sleep with an index of 5 events/h or more, leading to daytime impairment including sleepiness or behavioral problems. Children with restless sleep disorder have been found to have low ferritin levels. Studies with iron supplementation both oral or intravenous have been shown effective in clinically improving both nighttime and daytime symptoms. However objective data of the improvement is lacking. Repeating polysomnography is expensive, and alternative methods of assessing large muscle movements are needed. In this small case series we present actigraphy results in 3 children with restless sleep disorder collected for 1 week, a week before and 8 weeks after intravenous iron supplementation. Although actigraphy parameters were not highly consistent between our 3 patients, improvement in symptoms tend to parallel sleep parameters in actigraphy.. Chu ZYB, DelRosso LM, Mogavero MP, Ferri R. Actigraphy evaluation before and after intravenous ferric carboxymaltose in 3 children with restless sleep disorder.

Topics: Actigraphy; Child; Humans; Iron; Restless Legs Syndrome; Sleep; Sleep Wake Disorders

Recent work has identified clinical and polysomnographic features of a newly defined pediatric sleep disorder, restless sleep disorder (RSD). One of these features is low serum ferritin. In this retrospective, pilot study, we assess the response to iron supplementation. Children were given oral ferrous sulfate (FS) or intravenous ferric carboxymaltose (IV FCM).. Children 5-18 years old with a diagnosis of RSD were evaluated clinically. Serum ferritin, iron profile, and video-polysomnography were obtained at baseline. Oral or IV iron supplementation was offered as part of routine care. Oral FS was one 325 mg tablet daily or 3 mg/kg/day liquid for 3 months. IV FCM was 15 mg/kg, up to 750 mg as a single infusion. Adverse effects were assessed. Ferritin and iron profile were checked after 2-3 months. Eight weeks after FCM, the phosphorus level was checked. Clinical Global Impression (CGI) scale was obtained pre- and posttreatment.. A total of 15 children received oral FS and 15 IV FCM. Baseline RSD severity, age, gender, or pretreatment lab values did not differ significantly between groups. CGI-improvement median score was "minimally improved" after oral FS and "much improved" after IV FCM (effect size 1.008, p < 0.023). All iron parameters were found to be significantly higher after intravenous iron treatment than oral iron, especially ferritin (effect size 3.743, p < 0.00003). Adverse effects: constipation, three with FS; noncompliance, one with FS; syncope, one with FCM infusion; and hypophosphatemia, zero post-FCM.. In this retrospective, clinical case series, RSD responded to iron supplementation with improvement in both clinical and laboratory parameters. The response was greater with IV FCM than oral FS.

Topics: Adolescent; Anemia, Iron-Deficiency; Child; Child, Preschool; Ferric Compounds; Ferrous Compounds; Humans; Maltose; Pilot Projects; Retrospective Studies; Sleep Wake Disorders