Trials
Efficacy of ferrous fumarate with elemental iron 60 mg alternate-day, 120 mg alternate-day vs 60 mg once a day therapy in the treatment of iron deficiency anaemia: study protocol for a randomised controlled trial
By Chamila Dinushi Kukulege Mettananda, Randula Mallawa, Naveen Fernando and 8 others.
Abstract
Iron deficiency anaemia (IDA) is the world’s most common nutritional deficiency disorder, affecting 30% of the population. There is no consensus on the regimen for Fe supplementation in IDA. There is mixed evidence for reduced iron absorption when Fe is supplemented daily, due to hepcidin, the iron regulator, being produced. To compare the efficacy of ferrous fumarate, elemental iron 60 mg once a day, 60 mg every other day, and 120 mg every other day therapy in improving haemoglobin levels in IDA. A single-blind, parallel group randomised controlled trial. Patients treated at outpatient/inpatient departments of Colombo North Teaching Hospital, Sri Lanka. All consenting adults over 18 years of age with confirmed iron deficiency anaemia with a haemoglobin of 10 g/dL or less, with serum ferritin below 50 ng/mL. Consecutive eligible patients are randomly allocated to receive ferrous fumarate 60 mg once a day, 60 mg every other day, and 120 mg every other day for 12 weeks. ( N = 100 in each arm). Mean change in haemoglobin at week 12. The proportion of participants achieving a haemoglobin rise of 2 g/dL or more at week 12 and the rates of adverse drug reactions across the three treatment regimens. Recruitment started on 01 September 2024, with protocol version 2, dated 04.04.2024, approved by the Ethics Review Committee on 14.05.2024 and by the Sri Lanka Clinical Trials Registry on 26.08.2024. By 01 March 2026, 138 patients had been randomised. The required sample size should be achieved by 2027. The trial is registered in the Sri Lanka Clinical Trials Registry (Ref: SLCTR/2024/027; https://slctr.lk/trials/slctr-2024-027 ). Ethical clearance has been obtained from the Ethics Review Committee of the Faculty of Medicine, University of Kelaniya, Sri Lanka (Ref: P/35/03/2024). Informed written consent is obtained from all participants.