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.

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.