The benefit of supplementary feeding for wasted Malawian adults initiating ART.

Food insecurity is considered to be an important contributor to HIV associated wasting in sub-Saharan Africa. Low body mass index (BMI) is a strong risk factor for early mortality during antiretroviral therapy (ART). Nutritional supplementation has become standard of care in wasted patients starting ART in many countries in the region, but there is no unequivocal evidence base for this intervention. Against this background, we performed a retrospective study to compare food supplementation versus no nutritional intervention in wasted adults starting ART in Blantyre, Malawi. All patients received free nevirapine, lamivudine, and stavudine. Participants in an effectiveness trial of two food supplements received either corn-soy blend (CSB) or ready-to-use food spread (RUFS) during the first 14 weeks of ART. Results were compared with a historical control group receiving no food supplement that was part of an observational cohort study of outcomes of the same ART regimen. Characteristics on initiation of ART were similar in the three groups, except the use of cotrimoxazole prophylaxis which was more frequent in the food-supplemented groups. Linear regression analysis showed that increase in BMI was greatest in the RUFS group and better in the CSB group than in those receiving no food supplementation at 14 weeks. These differences were no longer significant at 26 weeks. Lower BMI, CD4 count and hemoglobin, WHO clinical stage IV, male gender, and not receiving cotrimoxazole prophylaxis were independent risk factors for mortality at 14 and 26 weeks in the logistic regression analysis. Supplementary food use was not directly associated with improved survival.

Supplementary Feeding in the Care of the Wasted HIV Infected Patient

Wasting and food insecurity are commonly seen in patients receiving antiretroviral treatment (ART) programs in sub-Saharan Africa and south Asia; and supplementary feeding is often offered in conjunction with ART. Evidence for the effectiveness of such supplementary feeding is scant. A randomised; investigatorblinded; controlled clinical trial of two types of supplementary food; corn/ soy blended flour and a ready-to-use peanut butterbased lipid paste; in wasted adults in Blantyre; Malawi is described and the results summarised. A historical control group who did not receive supplementary food is described as well. Provision of about half of the daily energy requirement as a supplementary food for 14 weeks resulted in more rapid restoration of a normal BMI; and the energy-dense; ready-to-use paste was associated with more rapid weight gain than the blended flour. Survival was similar among the 3 groups. The strong association between lower BMI and survival indirectly suggests that there may well be clinical benefit from supplementary feeding in this population. No differences were seen in ART adherence or quality of life with more rapid restoration of BMI. Further research is urgently needed concerning the widespread practice of supplementary feeding in HIV/ AIDS care to most effectively utilize this intervention

Nutritional status of Malawian adults on antiretroviral therapy 1 year after supplementary feeding in the first 3 months of therapy.

OBJECTIVE: To test the hypothesis that individuals on antiretroviral therapy (ART) for 3 months with a greater body mass index (BMI) as a result of supplementary feeding with ready-to-use fortified spread would maintain a higher BMI 9 months after the feeding ended. METHODS: Two cohorts of wasted adults with AIDS, after 12 months of ART and 3 months of supplementary feeding with either ready-to-use fortified spread, an energy dense lipid paste; or corn/soy blended flour, were assessed for clinical and anthropometric status, quality of life, and ART adherence after 3 and 9 months. RESULTS: 336 ART patients participated: 162 who had received ready-to-use fortified spread and 174 who had received corn/soy blended flour. 9 months after stopping food supplements, both groups had a similar BMI, fat-free body mass, hospitalization rate and mortality. Binary logistic regression modelling showed that lower BMI, lower CD4 count, and older age at baseline were associated with a higher risk of death (odds ratio for BMI = 0.63, 95% CI 0.47-0.79). Adherence to the ART regimen and quality of life were similar in both cohorts. CONCLUSION: While supplementary feeding with ready-to-use fortified spread can ameliorate the BMI, an established risk factor for mortality, this effect is sustained only during the time of the intervention. Supplementary feeding of wasted patients for longer than 3 months should be investigated.

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.

OBJECTIVE: To investigate the effect of two different food supplements on body mass index (BMI) in wasted Malawian adults with HIV who were starting antiretroviral therapy. DESIGN: Randomised, investigator blinded, controlled trial. SETTING: Large, public clinic associated with a referral hospital in Blantyre, Malawi. PARTICIPANTS: 491 adults with BMI <18.5. INTERVENTIONS: Ready-to-use fortified spread (n=245) or corn-soy blend (n=246). PRIMARY OUTCOMES: changes in BMI and fat-free body mass after 3.5 months. SECONDARY OUTCOMES: survival, CD4 count, HIV viral load, quality of life, and adherence to antiretroviral therapy. RESULTS: The mean BMI at enrolment was 16.5. After 14 weeks, patients receiving fortified spread had a greater increase in BMI and fat-free body mass than those receiving corn-soy blend: 2.2 (SD 1.9) v 1.7 (SD 1.6) (difference 0.5, 95% confidence interval 0.2 to 0.8), and 2.9 (SD 3.2) v 2.2 (SD 3.0) kg (difference 0.7 kg, 0.2 to 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 the CD4 count, HIV viral load, assessment of quality of life, or adherence to antiretroviral therapy were noted between the two groups. CONCLUSION: Supplementary feeding with fortified spread resulted in a greater increase in BMI and lean body mass than feeding with corn-soy blend. TRIAL REGISTRATION: Current Controlled Trials ISRCTN67515515.

A large-scale operational study of home-based therapy with ready-to-use therapeutic food in childhood malnutrition in Malawi.

Home-based therapy with ready-to-use therapeutic food (RUTF) for the treatment of malnutrition has better outcomes in the research setting than standard therapy. This study examined outcomes of malnourished children aged 6-60 months enrolled in operational home-based therapy with RUTF. Children enrolled in 12 rural centres in southern Malawi were diagnosed with moderate or severe malnutrition according to the World Health Organization guidelines. They were treated with 733 kJ kg(-1) day(-1) of RUTF and followed fortnightly for up to 8 weeks. Staff at each centre followed one of three models: medical professionals administered treatment (5 centres), patients were referred by medical professionals and treated by community health aids (4 centres), or community health aids administered treatment (3 centres). The primary outcome of the study was clinical status, defined as recovered, failed, died or dropped out. Regression modelling was conducted to determine what aspects of the centre (formal training of staff, location along a main road) contributed to the outcome. Of 2131 severely malnourished children and 806 moderately malnourished, 89% and 85% recovered, respectively. Thirty-four (4%) of the moderately malnourished children failed, with 20 (2%) deaths, and 61 (3%) of the severely malnourished children failed, with 29 (1%) deaths. Centre location along a road was associated with a poor outcome. Outcomes for severely malnourished children were acceptable with respect to both the Sphere guidelines and the Prudhon case fatality index. Home-based therapy with RUTF yields acceptable results without requiring formally medically trained personnel; further implementation in comparable settings should be considered.

The quality of the diet in Malawian children with kwashiorkor and marasmus.

Nutritionists have suggested that kwashiorkor is related to low dietary protein and/or antioxidant intake. This study explored the hypothesis that among Malawian children with severe malnutrition, those with kwashiorkor consume a diet with less micronutrient- and antioxidant-rich foods, such as fish, eggs, tomatoes and orange fruits (mango, pumpkin and papaya), than those with marasmus. A case-control method with a food frequency questionnaire was used to assess the habitual diet. Children with severe childhood malnutrition presenting to the central hospital in Blantyre, Malawi during a 3-month period in 2001 were eligible to participate. The food frequency questionnaire collected data about foods consumed by siblings <60 months of age in the home. It was assumed that the habitual diet of all siblings 1-5 years old in the same home was similar. Dietary diversity was assessed using a validated method, with scores that ranged from 0 to 7. Regression modelling was used to control for demographic and disease covariates. A total of 145 children with kwashiorkor and 46 with marasmus were enrolled. Children with kwashiorkor consumed less egg and tomato than those with marasmus: 17 (15) vs. 24 (31) servings per month for egg, mean (SD), P < 0.01 and 27 (17) vs. 32 (19) servings per month for tomato, P < 0.05. Children with kwashiorkor had a similar dietary diversity score as those with marasmus, 5.06 (0.99) vs. 5.02 (1.10), mean (SD). Further research is needed to determine what role consumption of egg and tomato may play in the development of kwashiorkor.

Home-based therapy for oedematous malnutrition with ready-to-use therapeutic food.

BACKGROUND: Standard recommendations are that children with oedematous malnutrition receive inpatient therapy with a graduated feeding regimen. AIM: To investigate exclusive home-based therapy for children with oedematous malnutrition. METHODS: Children with oedematous malnutrition, good appetite and no complications were treated at home with ready-to-use therapeutic food (RUTF) and followed up fortnightly for up to 8 wk. SETTING AND PARTICIPANTS: 219 children aged 1-5 y with oedema enrolled in one of two therapeutic nutritional studies in Malawi in 2003-2004. RESULTS: The overall recovery rate was 83% (182/219), and the case-fatality rate was 5% (11/219). For children with wasting and oedematous malnutrition, 65% (55/85) recovered and 7% (6/85) died. The average weight gain was 2.8+/-3.2 g/kg/d (mean+/-SD). CONCLUSION: This preliminary observation suggests that children with oedematous malnutrition and good appetite may be successfully treated with home-based therapy; a randomized, controlled trial to evaluate this is warranted.

Comparison of home-based therapy with ready-to-use therapeutic food with standard therapy in the treatment of malnourished Malawian children: a controlled, clinical effectiveness trial.

BACKGROUND: Childhood malnutrition is common in Malawi, and the standard treatment, which follows international guidelines, results in poor recovery rates. Higher recovery rates have been seen in pilot studies of home-based therapy with ready-to-use therapeutic food (RUTF). OBJECTIVE: The objective was to compare the recovery rates among children with moderate and severe wasting, kwashiorkor, or both receiving either home-based therapy with RUTF or standard inpatient therapy. DESIGN: A controlled, comparative, clinical effectiveness trial was conducted in southern Malawi with 1178 malnourished children. Children were systematically allocated to either standard therapy (186 children) or home-based therapy with RUTF (992 children) according to a stepped wedge design to control for bias introduced by the season of the year. Recovery, defined as reaching a weight-for-height z score > -2, and relapse or death were the primary outcomes. The rate of weight gain and the prevalence of fever, cough, and diarrhea were the secondary outcomes. RESULTS: Children who received home-based therapy with RUTF were more likely to achieve a weight-for-height z score > -2 than were those who received standard therapy (79% compared with 46%; P < 0.001) and were less likely to relapse or die (8.7% compared with 16.7%; P < 0.001). Children who received home-based therapy with RUTF had greater rates of weight gain (3.5 compared with 2.0 g . kg(-1) . d(-1); difference: 1.5; 95% CI: 1.0, 2.0 g . kg(-1) . d(-1)) and a lower prevalence of fever, cough, and diarrhea than did children who received standard therapy. CONCLUSION: Home-based therapy with RUTF is associated with better outcomes for childhood malnutrition than is standard therapy.

Supplemental feeding with ready-to-use therapeutic food in Malawian children at risk of malnutrition.

The study was a controlled, comparative clinical effectiveness trial of two supplementary feeding regimens in children at risk of malnutrition from seven centres in rural Malawi. Being at risk of malnutrition was defined as weight-for-height <85%, but >80% of the international standard. A stepped-wedge design with systematic allocation was used for assigning children to receive either ready-to-use therapeutic food (RUTF) (n=331) or micronutrient-fortified corn/soy-blend (n=41) for up to eight weeks. The primary outcomes were recovery, defined as weight-for-height >90%, and the rate of weight gain. Children receiving RUTF were more likely to recover (58% vs 22%; difference 36%; 95% confidence interval [CI] 20-52) and had greater rates of weight gain (3.1 g/kg.d vs 1.4 g/kg x d; difference 1.7; 95% CI 0.8-2.6) than children receiving corn/soy-blend. The results of this preliminary work suggest that supplementary feeding with RUTF promotes better growth in children at risk of malnutrition than the standard fortified cereal/legume-blended food.

Home-based treatment of malnourished Malawian children with locally produced or imported ready-to-use food.

OBJECTIVES: To determine the efficacy of home-based therapy with ready-to-use food (RTUF) in producing catch-up growth in malnourished children and to compare locally produced RTUF with imported RTUF for this purpose. METHODS: After a brief inpatient stabilization, 260 children with severe malnutrition were enrolled and systematically allocated to receive home therapy with either imported, commercially produced RTUF or locally produced RTUF. Each child received 730 kJ/kg/day and was followed up fortnightly. Children completed the study when they reached a weight-for-height Z score > -0.5 (WHZ), relapsed, died, or failed to achieve WHZ > -0.5 after 16 weeks. Analyses were stratified by human immunodeficiency virus (HIV) status. RESULTS: 78% of all children reached WHZ > -0.5, 95% of those with HIV-negative status and 59% of those with HIV-positive status. Eighty percent of those receiving locally produced RTUF and 75% of those receiving imported RTUF reached WHZ > -0.5. The difference between recovery rates was 5% (95% confidence interval [CI], -5-15%). The rate of weight gain was 0.4 g/kg/day (95% CI, -0.6, 1.4) greater among children receiving locally produced RTUF. The prevalence of diarrhea reported by mothers was 3.7% for locally produced RTUF and 4.3% for imported RTUF. After completion of home therapy and resumption of habitual diet for 6 months, 91% of all children maintained a normal WHZ. CONCLUSIONS: Home-based therapy with RTUF was successful in affecting complete catch-up growth. In this study, locally produced and imported RTUF were similar in efficacy in treating of severe childhood malnutrition.