Leaf concentrate as an alternative to iron and folic acid supplements for anaemic adolescent girls: a randomised controlled trial in India.

OBJECTIVE Despite public health campaigns based on Fe and folic acid supplements, Fe-deficiency anaemia remains highly prevalent among women in India. We investigated leaf concentrate as an alternative to Fe and folic acid supplements for treating anaemia in adolescent girls. DESIGN Randomised controlled two-arm trial over 3 months: one group received daily Fe and folic acid (IFA; 60 mg Fe, 500 microg folic acid); the other daily leaf concentrate (LC; 5 mg Fe, 13 microg folic acid). Hb concentration, mean cell volume, serum Fe, serum ferritin and total Fe-binding capacity were measured pre- and post-intervention. SETTING Jaipur, India. SUBJECTS One hundred and two adolescent girls aged 14-18 years. RESULTS Of the 102 girls randomized to the two arms of the trial, four (3.9 %) were severely anaemic (Hb < 7 g/dl), twenty-eight (27.5 %) were moderately anaemic (Hb > or = 7 g/dl, <10 g/dl) and seventy (68.6 %) were mildly anaemic (Hb > or = 10 g/dl, <12 g/dl). In the IFA group, eleven girls (20.4 %) withdrew due to side-effects, compared with one girl (2.1 %) in the LC group (P = 0.005). Total losses to follow-up were 14/54 in the IFA group and 2/48 in the LC group. At the end of the trial, none of the eighty-six remaining girls were severely anaemic, nine (10.5 %) were moderately anaemic and twenty-six (30.2 %) were mildly anaemic; fifty-one (59.3 %) had normal Hb levels (> or = 12 g/dl). After adjustment for baseline values, LC was as effective as IFA in improving serum Fe parameters and treating anaemia. CONCLUSIONS Leaf concentrate is an effective, and more palatable, alternative to Fe and folic acid supplements for treating anaemia in adolescent girls.