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Objective: The effectiveness of leaf concentrate powder (LCP) as a nutritional supplement was established in trials conducted among adolescent girls and pregnant women in India. Here we evaluate LCP, compared with skimmed milk powder (SMP), as a supplement for antiretroviral-naïve children living with HIV in a sub-Saharan African country.Design: Randomized controlled, two-arm, 6-month trial comparing effects of isoproteic (5 g) LCP (10 g daily) and SMP (15 g daily) on HIV-1 viral load, CD4+ cell count/percentage, weight/height-for-age, general blood parameters, diarrhoea, respiratory and HIV-related opportunistic infections.Setting: Bujumbura and Kirundo, Burundi.Subjects: Eighty-three HIV-positive, antiretroviral-naïve children aged 5-14 years: median (range) CD4+ count, 716 (361-1690) cells/mm3; log10 HIV-1 viral load, 4·39 (1·79-6·00).Results: LCP was equivalent to SMP in relation to HIV-specific blood parameters and did not demonstrate superiority over SMP in relation to Hb. Three children in each arm (LCP, 7·1 % (3/42); SMP, 7·3 % (3/41)) proceeded to antiretroviral therapy because their CD4+ counts fell below 350 cells/mm3. Children in the LCP group reported higher levels of appetite and overall health at 6 months. There were no differences in clinical events or any other outcome measures. LCP was less palatable than SMP to the children in this population, but there were few negative perceptions of appearance, texture and taste.Conclusions: LCP appears to be equivalent to SMP as a nutritional supplement in this population, despite slightly lower palatability. In relation to viral load and CD4+ count, equivalence may indicate no effect in either group. Effectiveness relative to no supplementation remains to be determined. [ABSTRACT FROM AUTHOR]

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, 500mg folic acid); the other daily leaf concentrate (LC; 5mg Fe, 13μg 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⩾7 g/dl, ,10 g/dl) and seventy (68·6%) were mildly anaemic (Hb⩾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 (P50·005). 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 (⩾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. [ABSTRACT FROM AUTHOR]