Effect of Intravenous Iron Therapy on Quality of Life in Non-Anemic Iron-Deficient Young Women with Fatigue

Introduction

Iron deficiency is defined as the presence of insufficient iron to maintain normal physiological function of tissues. Even in the absence of anemia, studies have demonstrated the effect of iron deficiency on cognition, exercise performance and endurance capacity. Menstruating women are at increased risk for developing iron deficiency. Studies have shown benefit of oral iron therapy in adult females but orally administered iron can be poorly absorbed and is often accompanied by gastrointestinal side effects impacting patient compliance. Intravenous iron therapy has been shown to be well tolerated and useful in adult patients but has not been well studied in a homogenous group of patients in the pediatric setting. The main objective of this study is to demonstrate the effect of a standardized regimen of intravenous iron on the quality of life of a prospective cohort of young women with low serum ferritin and symptoms of fatigue as measured by a standardized quality of life fatigue scale.

Methods

Our study design is a prospective observational study. We include young post-menarchal girls with serum ferritin < 20 ng/ml and symptoms of fatigue as documented by the standardized and validated Peds QL^TM Multidimensional Fatigue Scale (Score < 70). Only patients who have failed oral iron therapy due to poor response, non-compliance or side effects are included on our study. Patients with hemoglobin < 10g/dl are excluded from the study. Patients receive four 15-20 minute infusions of 200 mg intravenous iron sucrose given over a 14-day period. Hemodynamic stability is carefully monitored. Laboratory values including hemoglobin, iron, TIBC, iron saturations, ferritin, reticulocyte count and reticulocyte hemoglobin concentration are obtained prior to treatment, at the time of the fourth infusion, 6 weeks and 3 months after treatment. The Peds QL^TM Multidimensional Fatigue Scale, using child self-report and parent proxy-report is administered at these time points as well.

Results

Nine patients have been included in this study and recruitment is ongoing. Six adolescent girls (ages 16-18 years) have completed all four infusions. All the patients tolerated the infusions well without any severe adverse effects. The mean pre-treatment ferritin level was 11.33 ng/ml (SD 6.713) and the mean post-treatment ferritin level was 273.33ng/ml (SD 154.23) (p = 0.002); [95% CI: -402.427 to -121.57]. There was a statistically significant improvement in the quality of life and fatigue scores as measured by the standardized Peds QL^TM Multidimensional Fatigue Scale for both the patient and parent questionnaires. The mean score for the patients pre-treatment was 41.172 (SD 20.696) and post-treatment was 75.043 (SD 10.657) (p = 0.005); [95% CI: -55.268 to -12.476]. The mean score for the parents pre-treatment was 43.048 (SD 21.307) and post-treatment was 73.608 (SD 13.145) (p = 0.01); [95 % CI: -53.334 to -7.786]. The individual ferritin levels, hemoglobin levels and fatigue scores of the subjects that have completed all the infusions have been included in the Table. The patients who were not anemic before the iron infusions did not have a significant change in hemoglobin levels. The post-treatment hemoglobin levels for patient 5 and patient 6 were obtained at the fourth infusion.

Conclusion

Although our study population is small, our results demonstrate promise that intravenous iron objectively improves fatigue and quality of life in young women with iron deficiency and mild/no anemia. Intravenous iron appears to be well tolerated and effective in this adolescent age group and leads to a substantial increase in ferritin levels. In non-anemic patients, iron administration did not influence hemoglobin concentration. Therefore, the fatigue-reducing effects of iron therapy reflect the non-hematological functions of iron.