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

Abstract

Micah Manary, student, 4 Haroon Saloojee, research physician, 3 Mark J Manary, professor and senior scientist 1,4,5 ABSTRACT 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). Main outcome measures 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.

Preferences for food and nutritional supplements among adult people living with HIV in Malawi

“…RUTF shows promising results in achieving a more prompt restoration of BMI (14,27) and fatfree mass (27) , and is increasingly being used in nutrition supplementation programmes (18) . However, increasing evidence shows that the acceptance of RUTF is low among adult PLHIV (14,17) .…”

Development of a cross-over randomized trial method to determine the acceptability and safety of novel ready-to-use therapeutic foods

“…Determining the equivalence or non-inferiority of SMS-RUTFh to the current standard product, rather than its statistical superiority to prestated thresholds, represents an alternative study design used to validate robustly a novel therapy [33] but requires a large sample size [34]. Other randomized trials [3,18,28], comparing RUTF with alternative food-based therapies, did not apply these methods. It is also important to note that the method described here is designed to be used in conducting an acceptability trial that precedes a RCT of clinical efficacy.…”

“…They can be individually packaged and can therefore be used effectively in situations with non-optimal hygiene conditions [1]. RUTFs are popular in feeding programs [2], including human immunodeficiency virus/tuberculosis (HIV/TB) interventions [1,3], because their use has been associated with an increase in successful treatment rates for severe acute malnutrition (SAM) when compared to other conventional treatments [4]. However, at present, the high price of RUTFs and their low regional availability hampers widespread use [5].…”

“…The most common commercial brand of RUTF is Plumpy'nut [17], which was designed for pediatric use and is the only one that has been clinically tested in several different studies [3,[18][19][20][21][22]. In wasted adults, a number of factors have been shown to reduce compliance with Plumpy'nut including the taste of this pediatric formulation [23].…”

Adequacy of Nutrient Intake, Morbidity and Nutritional status of HIV and AIDS Infected Children at Pre and Post Amaranth Grain Supplementation

“…According to the study, food supplementation was associated with better adherence to ART, after adjusting for age, sex, baseline CD4 count, WHO stage and haemoglobin. In a randomized controlled trial from Malawi, comparing supplementary feeding with a ready-to-use fortified spread compared to corn-soy blended flour with similar energy composition, patients receiving fortified spread had greater increase in BMI and fat-free body mass than those receiving corn-soy blend [28]. In this study, the association between amaranth grain flour supplementation and adequacy of nutrient intake, nutritional status and morbidity of the study children was analysed.…”