(P24-032-24) Assessing the Efficacy of Bovine Lactoferrin to Correct Iron Deficiency Anaemia in Women of Reproductive Age: A Double Blind Randomized Controlled Trial in Mirpur, Dhaka

Objectives: This study assessed whether supplementing non-pregnant women with lactoferrin, an antimicrobial protein, is as effective as Ferrous sulfate supplementation in increasing hemoglobin levels.

Methods: We conducted a 3-arm double-blind, randomized, controlled, non-inferiority trial in Dhaka, Bangladesh. Non-pregnant, non-lactating women aged 18-49 who had iron deficiency anemia (defined as Hb levels less than 12 g/dl and ferritin levels less than 30 µg/L) were eligible and randomly assigned (1:1:1) to receive once-daily 60 mg Ferrous sulphate and 400μg folic acid supplement, or 200 mg bovine Lactoferrin and 400μg folic acid, or 400 mg bovine Lactoferrin and 400μg folic acid for 12 weeks. The primary efficacy endpoint was the mean Hb change from baseline to 12 weeks for each of these arms tested for noninferiority with a margin of −0.5 g/dl. A per-protocol analysis was used to assess the non-inferiority of the primary outcome. Participants completed three months of intervention and, with outcome measurement at 12 weeks, were considered to have finished the trial. This trial is registered with the Australian and New Zealand Clinical Trials Registry, ACTRN12617001455358.

Results: Between January 28, 2018, and October 3, 2018, we screened 4511 women and randomly assigned 555 iron-deficient anemic women to one of three treatment arms. Among them (63%) completed follow-up at 12 weeks, with no differences observed among the groups. Mean (95% confidence interval) change in Hb concentration from baseline to 12 weeks was -0.15 (-0.30 to 0.00) g/dl for 200 mg Lactoferrin, -0.03 (-0.19 to 0.13) g/dl for 400 mg Lactoferrin, and 1.08 (0.82 to 1.33) g/dl for the Ferrous sulfate arm. The corresponding mean Hb difference (95% CI) comparing the 200mg Lactoferrin and 400 mg Lactoferrin group to the Ferrous sulfate group was -1.22 (-1.55 to -0.89) g/dl and -1.10 (-1.43 to -0.78) g/dl, respectively.

Conclusions: Since the lower bound of the 95% CI of this effect estimate (-1.55 g/dl and -1.43 g/dl) was less than the predetermined noninferiority margin of –0.5 g/dl, we conclude that Lactoferrin was inferior to Ferrous sulfate regarding the primary efficacy outcome. Thus, our study does not endorse using unsaturated bovine lactoferrin supplementation to enhance iron status in non-pregnant women.

Funding Sources: Medical Research Council, UK and Saving Lives at Birth