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A randomized trial of ready-to-use supplementary food versus corn-soy blend plus as food rations for HIV-infected adults on antiretroviral therapy in rural Haiti.

ABSTRACT: The epidemics of food insecurity, malnutrition, and human immunodeficiency virus (HIV) frequently overlap. HIV treatment programs increasingly provide nutrient-dense ready-to-use supplementary foods (RUSFs) to patients living with HIV and food insecurity, but in the absence of wasting, it is not known if RUSF confers benefit above less costly food commodities.We performed a randomized trial in rural Haiti comparing an RUSF with less costly corn-soy blend plus (CSB+) as a monthly supplement to patients with HIV infection who were on antiretroviral therapy (ART) <24 months prior to study start. We compared 6- and 12-month outcomes by ration type in terms of immunologic response, body mass index (BMI), adherence to ART, general health quality of life, household food insecurity, and household wealth.A cohort of 524 patients with HIV receiving ART was randomized and followed over time. Median CD4 cell count at baseline was 339 cells/µL (interquartile range [IQR], 197-475 cells/µL) for the CSB+ group, and 341 cells/µL (IQR, 213-464/µL) for the RUSF group. Measured outcomes improved from baseline over time, but there were no statistically significant differences in change for BMI, household wealth index, hunger, general health perception score, or adherence to ART by ration type at 6 or 12 months. The RUSF group had higher CD4 count at 12 months, but this was also not statistically significant.In 12 months of follow-up, there was no statistically significant difference in outcomes between those receiving RUSF-based compared with CSB+-based rations in a cohort of HIV-infected adults on ART in rural Haiti.

SUBMITTER: Ivers LC

PROVIDER: S-EPMC3967824 | biostudies-other | 2014 Apr

REPOSITORIES: biostudies-other

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A randomized trial of ready-to-use supplementary food versus corn-soy blend plus as food rations for HIV-infected adults on antiretroviral therapy in rural Haiti.

Ivers Louise C LC Teng Jessica E JE Jerome J Gregory JG Bonds Matthew M Freedberg Kenneth A KA Franke Molly F MF

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20140217 8

<h4>Background</h4>The epidemics of food insecurity, malnutrition, and human immunodeficiency virus (HIV) frequently overlap. HIV treatment programs increasingly provide nutrient-dense ready-to-use supplementary foods (RUSFs) to patients living with HIV and food insecurity, but in the absence of wasting, it is not known if RUSF confers benefit above less costly food commodities.<h4>Methods</h4>We performed a randomized trial in rural Haiti comparing an RUSF with less costly corn-soy blend plus ( ...[more]

PMID: 24536058

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Project description:BackgroundMalnutrition during pregnancy in sub-Saharan Africa is associated with poor birth outcomes.ObjectiveThis study compared maternal and offspring anthropometry for moderately malnourished pregnant women receiving ready-to-use supplemental food (RUSF), a fortified corn-soy blend (CSB+) with a daily multiple micronutrient antenatal supplement [United Nations International Multiple Micronutrient Preparation (UNIMMAP)], or standard of care comprising CSB+ and iron and folic acid (IFA).DesignA single-blind randomized controlled clinical trial was conducted in southern Malawi among 1828 pregnant women with moderate malnutrition, defined as a midupper arm circumference (MUAC) ≥20.6 and ≤23.0 cm. Women received 1 of 3 dietary treatment regimens that provided ∼900 kcal/d and 33-36 g protein/d. Maternal and infant anthropometry were followed until the child was 3 mo old.ResultsNewborns had a mean length-for-age z score of -1.3 ± 1.2 and 22% were stunted at birth. Mothers receiving RUSF had the highest weight gain during supplementation (3.4 ± 2.6, 3.0 ± 2.2, and 3.2 ± 2.4 kg for the RUSF, CSB+ with UNIMMAP, and CSB+ with IFA groups, respectively; P = 0.03). Newborn birth weights and lengths were similar across intervention groups, but the incidence of newborns with a birth weight <2.4 kg (weight-for-age z score <-2) was higher in the CSB+ with UNIMMAP group than the other groups (17%, 18%, and 24% for the CSB+ with IFA, RUSF, and CSB+ with UNIMMAP groups, respectively; P = 0.02). At birth, HIV-exposed newborns had a similar length and weight as newborns without HIV exposure, but their head circumference was smaller (34.0 ± 1.5 and 34.3 ± 1.6 cm, respectively; P = 0.02). At 3 mo of age, HIV-exposed infants had smaller weights, lengths, and head and arm circumferences than infants without HIV exposure.ConclusionsRUSF improved maternal weight gain compared with CSB+ with UNIMMAP. The large amount of food given and the modest effect on linear growth in newborns suggests that stunting in utero is unlikely to be reduced by supplemental food alone. This trial was registered at clinicaltrials.gov as NCT02120599.

Project description:Inadequate energy and micronutrient intake during childhood is a major public health problem in developing countries. Ready-to-use supplementary food (RUSF) made of locally available food ingredients can improve micronutrient status and growth of children. The objective of this study was to develop RUSF using locally available food ingredients and test their acceptability.A checklist was prepared of food ingredients available and commonly consumed in Bangladesh that have the potential of being used for preparing RUSF. Linear programming was used to determine possible combinations of ingredients and micronutrient premix. To test the acceptability of the RUSF compared to Pushti packet (a cereal based food-supplement) in terms of amount taken by children, a clinical trial was conducted among 90 children aged 6-18 months in a slum of Dhaka city. The mothers were also asked to rate the color, flavor, mouth-feel, and overall liking of the RUSF by using a 7-point Hedonic Scale (1?=?dislike extremely, 7?=?like extremely).Two RUSFs were developed, one based on rice-lentil and the other on chickpea. The total energy obtained from 50 g of rice-lentil, chickpea-based RUSF and Pushti packet were 264, 267 and 188 kcal respectively. Children were offered 50 g of RUSF and they consumed (mean?±?SD) 23.8?±?14 g rice-lentil RUSF, 28.4?±?15 g chickpea based RUSF. Pushti packet was also offered 50 g but mothers were allowed to add water, and children consumed 17.1?±?14 g. Mean feeding time for two RUSFs and Pushti packet was 20.9 minutes. Although the two RUSFs did not differ in the amount consumed, there was a significant difference in consumption between chickpea-based RUSF and Pushti packet (p?=?0.012). Using the Hedonic Scale the two RUSFs were more liked by mothers compared to Pushti packet.Recipes of RUSF were developed using locally available food ingredients. The study results suggest that rice-lentil and chickpea-based RUSF are well accepted by children.ClinicalTrials.gov NCT01553877. Registered 24 January 2012.

Project description:BackgroundIn sub-Saharan Africa, severely immunocompromised HIV-infected individuals have a high risk of mortality during the first few months after starting antiretroviral therapy (ART). We hypothesise that universally providing ready-to-use supplementary food (RUSF) would increase early weight gain, thereby reducing early mortality compared with current guidelines recommending ready-to-use therapeutic food (RUTF) for severely malnourished individuals only.MethodsWe did a 2 × 2 × 2 factorial, open-label, parallel-group trial at inpatient and outpatient facilities in eight urban or periurban regional hospitals in Kenya, Malawi, Uganda, and Zimbabwe. Eligible participants were ART-naive adults and children aged at least 5 years with confirmed HIV infection and a CD4 cell count of fewer than 100 cells per μL, who were initiating ART at the facilities. We randomly assigned participants (1:1) to initiate ART either with (RUSF) or without (no-RUSF) 12 weeks' of peanut-based RUSF containing 1000 kcal per day and micronutrients, given as two 92 g packets per day for adults and one packet (500 kcal per day) for children aged 5-12 years, regardless of nutritional status. In both groups, individuals received supplementation with RUTF only when severely malnourished (ie, body-mass index [BMI] <16-18 kg/m2 or BMI-for-age Z scores <-3 for children). We did the randomisation with computer-generated, sequentially numbered tables with different block sizes incorporated within an online database. Randomisation was stratified by centre, age, and two other factorial randomisations, to 12 week adjunctive raltegravir and enhanced anti-infection prophylaxis (reported elsewhere). Clinic visits were scheduled at weeks 2, 4, 8, 12, 18, 24, 36, and 48, and included nurse assessment of vital status and symptoms and dispensing of all medication including ART and RUSF. The primary outcome was mortality at week 24, analysed by intention to treat. Secondary outcomes included absolute changes in weight, BMI, and mid-upper-arm circumference (MUAC). Safety was analysed in all randomly assigned participants. Follow-up was 48 weeks. This trial is registered with ClinicalTrials.gov (NCT01825031) and the ISRCTN registry (43622374).FindingsBetween June 18, 2013, and April 10, 2015, we randomly assigned 1805 participants to treatment: 897 to RUSF and 908 to no-RUSF. 56 (3%) were lost-to-follow-up. 96 (10·9%, 95% CI 9·0-13·1) participants allocated to RUSF and 92 (10·3%, 8·5-12·5) to no-RUSF died within 24 weeks (hazard ratio 1·05, 95% CI 0·79-1·40; log-rank p=0·75), with no evidence of interaction with the other randomisations (both p>0·7). Through 48 weeks, adults and adolescents aged 13 years and older in the RUSF group had significantly greater gains in weight, BMI, and MUAC than the no-RUSF group (p=0·004, 0·004, and 0·03, respectively). The most common type of serious adverse event was specific infections, occurring in 90 (10%) of 897 participants assigned RUSF and 87 (10%) of 908 assigned no-RUSF. By week 48, 205 participants had serious adverse events in both groups (p=0·81), and 181 had grade 4 adverse events in the RUSF group compared with 172 in the non-RUSF group (p=0·45).InterpretationIn severely immunocompromised HIV-infected individuals, providing RUSF universally at ART initiation, compared with providing RUTF to severely malnourished individuals only, improved short-term weight gain but not mortality. A change in policy to provide nutritional supplementation to all severely immunocompromised HIV-infected individuals starting ART is therefore not warranted at present.FundingJoint Global Health Trials Scheme (UK Medical Research Council, UK Department for International Development, and Wellcome Trust).

Dataset Information

A randomized trial of ready-to-use supplementary food versus corn-soy blend plus as food rations for HIV-infected adults on antiretroviral therapy in rural Haiti.

Publications

A randomized trial of ready-to-use supplementary food versus corn-soy blend plus as food rations for HIV-infected adults on antiretroviral therapy in rural Haiti.

Similar Datasets

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