Srushti Hospital and Maternity Hospital, Aurangabad, India
Research Article
Real-World Effectiveness of Livogen®Z an oral iron, folic acid, plus zinc fixed dose combination supplement in pregnant and non-pregnant women with Iron Deficiency Anaemia - Insights from a phase IV Observational study in India (LIBERTY)
Author(s): Parag Biniwale, Lakshmi Swetha Karlapudi, Nimisha Pagare, Roger D Gibb, Sue Aspley and Poonam Sule*
Background: Iron Deficiency Anaemia (IDA) is a major health concern in India. Livogen®Z (manufactured by Procter and Gamble Health Ltd.) combines ferrous fumarate (152mg), folic acid (750mcg) and zinc sulphate (61.8mg) for management of anaemia, but real-world data from India is scarce.
Methods: A phase IV, prospective observational study was conducted at four sites in India in pregnant and non pregnant women with IDA aged 18-55 years. Subjects received Livogen®Z tablet twice daily for 90 days between June 2022 and October-2023. The primary objective was to evaluate the Change from Baseline (CFB) in Hemoglobin (Hb) after 90 days of treatment. CFB at Days 21 and 60, CFB in ferritin at end-of-study. IDA symptoms and Adverse Events (AE) were secondary endpoints.
Results: Of the 102 recruited subjects, data for.. View more»