Ndekha MJ, van Oosterhout JJG, Zijlstra EE, Manary M, Saloojee J, Manary MJ. Supplementary feeding with either ready-to-use fortified spread or corn-soy blend in wasted adults starting antiretroviral therapy in Malawi: randomised, investigator blinded, controlled trial. BMJ 2009;338:b1867.
The prevalence of wasting (body mass index [BMI]<18.5) in adults with advanced HIV infection in sub-Saharan Africa is 20%-40%.(1,2) Mortality during the initial months of antiretroviral therapy (ART) is high in sub-Saharan Africa, and low BMI is an independent risk factor for early mortality.(3) In Malawi, supplementary feeding in conjunction with ART is advocated as the standard of care for wasted HIV-infected adults. Supplementary feeding may improve outcomes in wasted HIV-infected patients receiving ART; however, there is limited research that provides evidence of the benefit of supplementary feeding in this population.(4).
To investigate the effect of two different food supplements -- fortified spread versus corn-soy blend -- on BMI in wasted Malawian adults with HIV who were starting ART.
The ART clinic of Queen Elizabeth Central Hospital, a referral hospital in Blantyre, Malawi.
Randomised, investigator blinded, controlled trial.
A total of 1343 adults attending the ART clinic of Queen Elizabeth Central Hospital from January 2006 to April 2007 were assessed for eligibility. Eligible adults were age ≥18 years, HIV-infected , me the eligibility criteria for ART according to the Malawian national HIV treatment guidelines (WHO clinical stage III or IV or any WHO stage with a CD4 cell count of <250/mm3), and initiating ART with a BMI of <18.5. Exclusion criteria were pregnancy and lactation or participation in another supplementary feeding programme. There were 491 eligible adults enrolled and randomised to the two treatment arms: 245 in the fortified spread arm and 246 in the corn-soy blend arm.
Participants were seen at the clinic at initiation of ART and after two, six, 10, and 14 weeks. At each visit study staff assessed clinical status, administered questionnaires on quality of life and adherence to ART, and measured body weight, bioelectrical impedance, and waist and mid-upper arm circumferences. Researchers took blood samples at enrollment and at 14 weeks to measure serum albumin concentration, hemoglobin concentration, CD4 cell count, and HIV viral load.
Dietary intake was assessed with three different methods: the total number of different foods consumed, whether animal products were consumed or not, and a 23-point dietary diversity score. Supplementary foods were dispensed to the participants in allocations that provided equivalent amounts of energy. The amounts of each supplement given were determined to provide about 50% of the daily estimated average energy requirements of the participants. Both groups of participants were advised to consider the food supplements as part of their medical treatment and not to share with others.
Primary outcomes included changes in BMI and fat-free body mass after 14 weeks. Secondary outcomes included survival, CD4 count, HIV viral load, serum albumin concentration, hemoglobin concentration, quality of life, and adherence to ART.
The mean BMI at enrollment was 16.5 in both groups. Seventeen (3.4%) participants were lost to follow-up, and 21 (4.3%) were known to be alive but missed their 3.5-month clinic visit and no anthropometric measurements made. No adverse reactions to either food were reported. After 14 weeks, average weight gain in patients receiving supplementary feeding was 13% of initial body mass among those receiving fortified spread and 10% in those receiving corn-soy blend. Patients receiving fortified spread had a greater increase in BMI and fat-free body mass than had those receiving corn-soy blend: 2.2 (SD 1.9) versus 1.7 (SD 1.6) (difference 0.5, 95% confidence interval [CI]: 0.2-0.8), and 2.9 kg (SD 3.2 kg) versus 2.2kg (SD 3.0 kg) (difference 0.7kg,, 95% CI: 0.2 kg-1.2 kg), respectively. The mortality rate was 27% for those receiving fortified spread and 26% for those receiving corn-soy blend. No significant differences in CD4 count, HIV viral load, assessment of quality of life, or adherence to ART were noted between the two groups.
In wasted patients initiating ART, supplementary feeding with fortified spread resulted in a greater increase in BMI and lean body mass than feeding with corn-soy blend. There were, however, no differences observed in mortality, CD4 count, viral load, adherence to ART, or quality of life between the two arms.
This RCT was of good quality. Randomization was conducted using sealed, unmarked opaque envelopes containing unique numbers from 1 to 500 (using block randomisation of 50) that were allocated to participants. A designated staff member matched the numbers with the food assignment and dispensed the appropriate food during the intervention period. All other staff members, including the clinicians managing the ART program and the nutritionist were blinded to the dietary assignment. Participants were not blinded to the food assignment because the blended soy-corn flour was distinct in appearance compared with the fortified peanut paste. Loss to follow-up in the study was relatively low at 3.4%.
The findings from this study are consistent with previous findings demonstrating greater weight-for-height improvement in severely malnourished Malawian children with HIV who received fortified spread compared to those receiving corn-soy blend(5) and programmatic data from rural Malawi reporting greater weight gain among Malawian adults receiving fortified spread compared to those receiving corn-soy blend.
This study did not show a survival benefit associated with a specific supplementary feeding method and was underpowered to detect small differences in survival. Furthermore, it did not measure the long-term clinical benefits of supplementary feeding. Further research needs to be done to evaluate whether the anthropometric benefits observed would lead to improved clinical outcomes. Additionally, given that fortified spread costs approximately three times as much as corn-soy blend per patient per month ($16 vs. $5.40), the authors acknowledge that formal cost benefit analyses are required to determine whether supplementary feeding strategies are cost effective when compared with other elements of clinical care for HIV-infected adults.
- Dannhauser A, van Staden AM, van der Ryst E, Nel M, Marais N, Erasmus E, et al. Nutritional status of HIV-1 seropositive patients in the Free State Province of South Africa: anthropometric and dietary profile. Eur J Clin Nutr 1999;53:165-73.
- Van der Sande MAB, van der Loeff MFS, Aveika AA, Sabally S, Togun T, Sarge-Njie R, et al. BMI at time of HIV diagnosis: a strong and independent predictor of survival. J Acquir Immune Defic Syndr 2004;37:1288-94.
- Zachariah R, Fitzgerald M, Massaquoi M, Pasulani O, Arnould L, Makombe S, et al. Risk factors for high early mortality in patients on antiretroviral treatment in a rural district of Malawi. AIDS 2006;20:2355-60.
- Mahlungulu S, Grobler LA, Visser ME, Volmink J. Nutritional interventions for reducing morbidity and mortality in people with HIV. Cochrane Database Syst Rev 2007;(3):CD004536.
- Ndekha MJ, Manary MJ, Ashorn P, Briend A. Home-based therapy with ready-to-use therapeutic food is of benefit to malnourished, HIV-infected Malawian children. Acta Paed 2005;94:222-5.