Low-Dose Iron is Safer, Tolerable and Equally Effective to High-Dose Iron in Improving Iron Status in Mild-Anemic Female Participants

Gaurav Jain, Anshul Gupta, Abha Mishra, Nilesh Chandra, Musarrat Warsi, Shadab Md, Shahid Karim, Reshma Parekar and Abhishek Dhama

Background and Objective: Despite being mainstay treatment for iron deficiency anemia, use of oral iron is limited due to increased incidence of unwanted GI effects. New evidences suggested that the unwanted effects are predominantly due to excess free or unbound iron in the body and are linked to dose and form of iron. Thus, a pilot clinical study was conducted in female subjects with mild anemia to evaluate the safety, tolerability and efficacy of low-dose iron chelate as an alternative to high-dose iron salt. Materials and Methods: A total of 12 subjects were randomized into 2 groups (n = 6) to receive either high-dose iron or low-dose iron, orally once daily for 4 weeks. At baseline and post-treatment, the gastrointestinal (GI) inflammation, C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR) were assessed. For safety, changes in Estimated Glomerular Filtration Rate (e-GFR), Blood Urea Nitrogen (BUN), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) were determined. The degree of discomfort from nausea, vomiting, abdominal pain, metallic taste, GI upset and blackening of stools was scored on a scale of 0 to 3. The Hb response, serum-ferritin and total iron binding capacity were determined for iron status. Results: The WBC scintigraphy indicated GI inflammation in two out of six subjects in the HDI group (33.3%), however, no inflammation was observed in the LDI group. The post-treatment changes in ESR, e-GFR, BUN, AST and ALT were not significantly different from the baseline in both groups, however, a significant decrease (p<0.05) in CRP was observed in both HDI and LDI groups. Symptom-based scoring showed that LDI treatment (0.86) was better tolerated than HDI treatment (1.86). Both treatments showed a comparable rise in Hb. Conclusion: The low-dose iron chelate was found to be safer, tolerable and equally effective to high-dose ferrous ascorbate in improving iron status.

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