A Prospective Randomized, Open-Label, Parallel-Group Study to Evaluate the Efficacy and Safety of Two Different Iron Formulations

Abstract

Background: Deficiency of iron, folic acid, and vitamin B12 (cobalamin) is common. Iron-deficiency is a common cause of anaemia world-wide. Nutritional deficiencies of folate, vitamin B12 and A, and C are other leading causes of anaemia.
Methods: In this prospective, randomized, parallel-group study the efficacy and safety of tablet formulation containing combination of ferrous ascorbate, folic acid and cyanocobalamin (Treatment A) was evaluated and compared with tablet formulation containing combination of ferrous ascorbate and folic acid (Treatment B) in treatment of low hemoglobin level. The levels of haemoglobin, haematocrit, vitamin B12, ferritin, and total red blood cell count were assessed in each treatment group during screening, on Day 30, and Day 60. Results: Tablet formulation containing combination of ferrous ascorbate, folic acid and cyanocobalamin (Treatment A) demonstrated 23.52% rise in haemoglobin level from baseline to Day 60 whereas the rise in Treatment B, a combination tablet of ferrous ascorbate and folic acid was 14.15%. Similar result was obtained for all other haematological parameters, serum ferritin and vitamin B12. Both the treatments were safe and tolerable and no adverse events were reported in the study. Conclusion: Adding cyanocobalamin to iron supplements containing combination of ferrous ascorbate and folic acid provides better efficacy in improving haematological parameters (haemoglobin, haematocrit, and total red blood cell count), serum ferritin, and vitamin B12 level.