Poster Theater Flash Session
Vitamins and Minerals
1. 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 bLf
3. To compare the side-effects of the treatments
Methods : Design: Non-inferiority, double-blind, individually RCT in non-pregnant WRA with iron deficiency anemia (Hb < 12 g/dl & serum ferritin < 30 μg/L)
Setting: Mirpur, Dhaka, Bangladesh
Participants: 555 non-pregnant, non-lactating women of 15-49 years.
Interventions: Women 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.
Outcomes:Serum 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.
Results : Women 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
Ferrous 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 Sources :
Saving Lives at Birth and Medical Research Council, UK