Assessing the Efficacy of Bovine Lactoferrin to Correct Iron Deficiency Anemia in Non-pregnant Non-lactating Women: A Randomized Controlled Trial (FS08-02-19)

Abstract

Objectives1. To determine if bovine lactoferrin (bLf) is at least as effective as oral ferrous sulfate in iron deficiency anemia in non-pregnant women of reproductive age (WRA)2. To determine the optimal dose of oral bLf3. To compare the side-effects of the treatments MethodsDesign: Non-inferiority, double-blind, individually RCT in non-pregnant WRA with iron deficiency anemia (Hb <12 g/dl & serum ferritin <30 μg/L) SettingMirpur, Dhaka, Bangladesh Participants555 non-pregnant, non-lactating women of 15–49 years. InterventionsWomen were allocated individually (1:1:1) in three arms. Arm A, B and C received daily oral 200 mg bLf, 400 mg bLf and 60 mg ferrous sulfate. All received 400 μg of folic acid daily. Treatment was for 12 weeks. OutcomesSerum Hb and serum ferritin at baseline and every 30 days for 3 months. Inflammatory markers: C-reactive protein (CRP); alpha(1)-Acid glycoprotein (AGP); hepcidin, at baseline and end line. Possible adverse effects were assessed. ResultsWomen on 200 mg bLf had a decrease in Hb of 0.3 g/dl (95% CI, −0.60 to 0.00 g/dl, P = 0.05), women on 400 mg bLf arm had no change in Hb: 0.0 g/dl (95% CI, −0.32 to 0.32 g/dl, P = 1.00), and women on ferrous sulfate arm had an increase in Hb: 1.1 g/dl (95% CI, 0.83 to 1.37 g/dl, P < 0.0001).Women on 200 mg bLf had an increase in ferritin: 2.8 μg/l (95% CI, 0.38 to 5.22 μg/l, P = 0.02), women on 400 mg bLf had an increase in ferritin: 3.5 μg/l (95% CI, 0.64 to 6.36 μg/l, P = 0.02) and women on ferrous sulfate arm had an increase in ferritin: 41.1 μg/l (95% CI, 35.74 to 46.47 μg/l, P < 0.0001).There were no significant differences in AGP and CRP between arms at the base line (P = 0.38 and 0.95) and end line (P = 0.87 and 0.14). Those on ferrous sulfate had a significant increase in hepcidin concentration after 90 days (P = .000).Abdominal pain, indigestion, diarrhea and black stool were significantly higher on ferrous sulfate group. There were no differences for other side-effects across treatment arms ConclusionsFerrous sulfate has better efficacy than bLf for iron deficiency anemia in non-pregnant non-lactating women of reproductive age in urban Bangladesh. This lactoferrin product may be inactive, or there may have been inadequate dietary iron for bLF to promote its absorption. Funding SourcesSaving Lives at Birth and Medical Research Council, UK.