Abstract
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. 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. Bujumbura and Kirundo, Burundi. 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). 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. 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.
Highlights
leaf concentrate powder (LCP) appears to be equivalent to skimmed milk powder (SMP) as a nutritional supplement in this population, despite slightly lower palatability
Guidelines for incorporating nutritional support into care programmes for HIV-infected children are available for local adaptation[2] and nutritional support services appear to be generally available at HIV care and treatment sites in sub-Saharan Africa[3]
We investigated the potential benefits of dried lucerne leaf concentrate as a nutritional supplement for HIV-infected antiretroviral therapy (ART)-naïve children living in two cities in Burundi
Summary
Study population and recruitment Our target population was antiretroviral-naïve HIV-positive children aged 5–14 years. Children were recruited from two clinical centres (in Bujumbura and Kirundo) run by the Association Nationale de Soutien aux Séropositifs et malades du Sida (ANSS; National Association of Support for People Living with HIV and AIDS). Founded in 1993, ANSS’ mission is to promote the prevention of HIV transmission and to improve the well-being of people living with and affected by HIV. The ANSS was the first Burundian civil society organization to provide HIV services to people living with HIV, including the distribution of ART. Recruitment was conducted by medical staff at the two centres, who identified eligible children at routine clinic appointments to which HIV-positive children are invited for medical and psychosocial monitoring purposes. The same staff explained the purpose of the study to children and their parent(s)/guardian(s), who were provided with a study information sheet and consent form in the local language (Kirundi)
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