Department of Biostatistics, The Procter and Gamble Company, Mason, United States of America
Original Research Article
Management of Iron Deficiency Anemia with Fixed Dose Combination of Ferrous Gluconate, Multivitamins and Multi-mineral Capsule: A 12 Week, Open Label Single Arm Prospective, Non-Interventional (Observational) Study in Philippines
Author(s): Christopher Joseph L. Soriano, V Abalos, CM Romero, R. Manalastas, G Villanueva, Poonam Sule*, Roger D Gibb, Sue Aspley and NS Comia
Aim: The study evaluated the efficacy and safety of an Iron+multivitamin and multi mineral capsule (SB+) capsule
in subjects with mild to moderate Iron Deficiency Anemia (IDA).
Methods: This was a Phase IV/post-marketing, open label, single arm, prospective, non-interventional study to
evaluate the SB+ capsule’s performance in real life scenario. The study enrolled 97 female subjects aged ≥ 15 years to
≤ 55 years (mean ± SD age: 34.9 ± 10.24 years) with mild to moderate IDA. The primary efficacy outcome was mean
Hemoglobin (Hb) concentration after administering an SB+ capsule orally for up to 90 days. 66 subjects received
30 mg elemental iron once a day and 31 subjects received 60 mg elemental iron twice a day at baseline depending
on their anemia status. The secondary efficacy outcomes were change i.. View more»