A novel fortified blended flour, corn-soy blend "plus-plus," is not inferior to lipid-based ready-to-use supplementary foods for the treatment of moderate acute malnutrition in Malawian children. Effectiveness of ready-to-use therapeutic food compared to a corn/soy-blend-based pre-mix for the treatment of childhood moderate acute malnutrition in Niger. Supplementary feeding with fortified spreads results in higher recovery rates than with a corn/soy blend in moderately wasted children. Zinc supplementation in malnourished children with persistent diarrhea in Pakistan. Effect of total enteral nutrition on the short-term outcome of severely malnourished cirrhotics. A randomized controlled trial. Randomized comparison of 3 types of micronutrient supplements for home fortification of complementary foods in Ghana: effects on growth and motor development. Efficacy of a foodlet-based multiple micronutrient supplement for preventing growth faltering, anemia, and micronutrient deficiency of infants: the four country IRIS trial pooled data analysis. Comparison of the effects of two early intervention strategies on the health outcomes of malnourished hemodialysis patients. A ready-to-use therapeutic food containing 10% milk is less effective than one with 25% milk in the treatment of severely malnourished children.
Children with moderate acute malnutrition (MAM) are often treated with fortified blended flours, most commonly a corn-soy blend (CSB). However, recovery rates remain <75%, lower than the rate achieved with peanut paste-based ready-to-use supplementary foods (RUSFs). To bridge this gap, a novel CSB recipe fortified with oil and dry skim milk, "CSB++," has been developed.
                In this trial we compared CSB++ with 2 RUSF products for the treatment of MAM to test the hypothesis that the recovery rate achieved with CSB++ will not be >5% worse than that achieved with either RUSF.
                We conducted a prospective, randomized, investigator-blinded, controlled noninferiority trial involving rural Malawian children aged 6-59 mo with MAM. Children received 75 kcal CSB++ · kg(-1) · d(-1), locally produced soy RUSF, or an imported soy/whey RUSF for ≤12 wk.
                The recovery rate for CSB++ (n = 763 of 888; 85.9%) was similar to that for soy RUSF (795 of 806, 87.7%; risk difference: -1.82%; 95% CI: -4.95%, 1.30%) and soy/whey RUSF (807 of 918, 87.9%; risk difference: -1.99%; 95% CI: -5.10%, 1.13%). On average, children who received CSB++ required 2 d longer to recover, and the rate of weight gain was less than that with either RUSF, although height gain was the same among all 3 foods studied.
                A novel, locally produced, fortified blended flour (CSB++) was not inferior to a locally produced soy RUSF and an imported soy/whey RUSF in facilitating recovery from MAM. The recovery rate observed for CSB++ was higher than that for any other fortified blended flour tested previously. This trial is registered at clinicaltrials.gov as NCT00998517. Standard nutritional treatment of moderate acute malnutrition (MAM) relies on fortified blended flours though their importance to treat this condition is a matter of discussion. With the newly introduced World Health Organization growth standards, more children at an early stage of malnutrition will be treated following the dietary protocols as for severe acute malnutrition, including ready-to-use therapeutic food (RUTF). We compared the effectiveness of RUTF and a corn/soy-blend (CSB)-based pre-mix for the treatment of MAM in the supplementary feeding programmes (SFPs) supported by Médecins Sans Frontières, located in the Zinder region (south of Niger). Children measuring 65 to <110 cm, newly admitted with MAM [weight-for-height (WHM%) between 70% and <80% of the NCHS median] were randomly allocated to receive either RUTF (Plumpy'Nut®, 1000 kcal day(-1)) or a CSB pre-mix (1231 kcal day(-1)). Other interventions were similar in both groups (e.g. weekly family ration and ration at discharge). Children were followed weekly up to recovery (WHM% ≥ 85% for 2 consecutive weeks). In total, 215 children were recruited in the RUTF group and 236 children in the CSB pre-mix group with an overall recovery rate of 79.1 and 64.4%, respectively (p < 0.001). There was no evidence for a difference between death, defaulter and non-responder rates. More transfers to the inpatient Therapeutic Feeding Centre (I-TFC) were observed in the CSB pre-mix group (19.1%) compared to the RUTF group (9.3%) (p = 0.003). The average weight gain up to discharge was 1.08 g kg(-1) day(-1) higher in the RUTF group [95% confidence interval: 0.46-1.70] and the length of stay was 2 weeks shorter in the RUTF group (p < 0.001). For the treatment of childhood MAM in Niger, RUTF resulted in a higher weight gain, a higher recovery rate, a shorter length of stay and a lower transfer rate to the I-TFC compared to a CSB pre-mix. This might have important implications on the efficacy and the quality of SFPs. Moderate childhood wasting is defined as having a weight-for-height Z-score (WHZ) < -2, but > or = -3. These children are typically given fortified corn/soy blended flour (CSB), but this intervention has shown limited effectiveness. Fortified spreads (FS) can be used as supplementary foods instead; they are energy-dense, lipid-based pastes with added powdered micronutrients. In this randomized clinical effectiveness trial, the recovery rates were compared among children with moderate wasting who received either milk/peanut FS, soy/peanut FS, or CSB. Children received isoenergetic quantities of food, 314 kJ x kg(-1) x d(-1), for up to 8 wk with biweekly follow-up. The primary outcome was recovery, defined as having a WHZ > -2. Time-event analysis was used to compare the recovery rate. A total of 1362 children were enrolled in the study. Children receiving soy/peanut FS had a similar recovery rate to those receiving milk/peanut FS and children in either FS group were more likely to recover than those receiving CSB (80% in both FS groups vs. 72% in the CSB group; P < 0.01). The rate of weight gain in the first 2 wk was greater among children receiving milk/peanut FS (2.6 g x kg(-1) x d(-1), n = 465) or children receiving soy/peanut FS (2.4 g x kg(-1) x d(-1), n = 450) than among children receiving CSB (2.0 g x kg(-1) x d(-1), n = 447; P < 0.05). Rates of length gain did not differ among the 3 groups. A total of 8% of children in each feeding group developed edema, indicative of severe malnutrition, while receiving supplemental feeding. We conclude that FS are superior supplementary foods to CSB for moderately wasted Malawian children. To evaluate the potential benefit of dietary supplementation of a rice-lentil (Khitchri) and yogurt diet with 3 mg/kg/d of elemental zinc (as zinc sulfate) in hospitalized malnourished children (age 6-36 months) with persistent diarrhea for 14 days.
                Randomized, double-blind placebo-controlled trial.
                Nutrition Research Ward at the National Institute of Child Health, Karachi, Pakistan, where children were admitted for 14 days of inpatient supervised rehabilitation.
                Primary outcome: overall weight gain by day 14. Secondary outcomes: overall energy intake, stool output, time to diarrheal recovery and weight gain (>/=3 days), plasma zinc, copper, prealbumin, and insulin-like growth factor-1.
                Of 87 children randomized for supplementation with either zinc or placebo, the two groups were comparable at admission in terms of severity and duration of diarrhea, as well as nutritional and anthropometric parameters. The overall weight gain, stool volume, stool frequency, as well as the time taken for diarrheal recovery or steady weight gain, were comparable for both supplemented children and controls. Supplemented children had a significant improvement in plasma zinc levels and serum alkaline phosphatase by day 14 of therapy in comparison with controls. Plasma copper levels were low in both groups at admission and although an increase was seen in control children, levels decreased further after zinc supplementation. There was no significant difference between the two groups for hemoglobin, serum albumin, prealbumin, and plasma insulin-like growth factor-1 increments during the course of therapy. Evaluation of primary and secondary outcome criteria among the subset of children with plasma zinc levels <60 microg/d at admission did not reveal any significant differences.
                Although there was satisfactory recovery in malnourished children with persistent diarrhea receiving the Khitchri-yogurt diet, there was no evidence of improved weight gain or acceleration of recovery from diarrhea with zinc supplementation. In contrast, the reduction in plasma copper levels in zinc-supplemented malnourished children suggests that caution should be exercised in supplementing severely malnourished children with zinc alone. Thirty-five severely malnourished cirrhotic patients were randomized to receive either enteral-tube feeding as the sole nutritional support (n = 16) or an isocaloric, isonitrogenous, low-sodium standard oral diet (n = 19). Both groups were homogeneous regarding age, sex distribution, etiology of liver cirrhosis, history of previous complications, clinical status, liver and renal function, modified Child's score, and nutritional status at admission. The enteral formula diet was energy dense, containing 40 mmol Na/day, whole protein plus branched-chain amino acids, medium- and long-chain triglycerides, and maltodextrin. It supplied 2115 kcal/day. The amount of vitamins and trace elements was at the upper limit of the recommended dietary allowances. The orally fed patients were encouraged to eat all meals served. Total enteral nutrition was well tolerated without major complications. Serum albumin and Child's score improved in the enterally fed patients but not in controls. Mortality rate while in the hospital was lower in patients on enteral feeding than in controls (12% vs 47%). These results show that total enteral nutrition is safe and effective in improving the short-term clinical outcome in severely malnourished cirrhotics. The low micronutrient content of complementary foods is associated with growth faltering in many populations. A potential low-cost solution is the home fortification of complementary foods with Sprinkles (SP) powder, crushable Nutritabs (NT) tablets, or energy-dense (108 kcal/d), fat-based Nutributter (NB).
                The objective was to test the hypothesis that multiple micronutrients added to home-prepared complementary foods would increase growth and that the effect would be greatest in the presence of added energy from fat.
                We randomly assigned 313 Ghanaian infants to receive SP, NT, or NB containing 6, 16, and 19 vitamins and minerals, respectively, daily from 6 to 12 mo of age. We assessed anthropometric status at 6, 9, and 12 mo; micronutrient status at 6 and 12 mo; motor development at 12 mo; and morbidity weekly. Infants (n = 96) not randomly selected for the intervention (nonintervention; NI) were assessed at 12 mo.
                The groups did not differ significantly at baseline, except that the NB group had a higher proportion of boys and weighed slightly more. The dropout rate (15/313) was low. At 12 mo, after control for initial size, the NB group had a significantly greater weight-for-age z score (WAZ) (-0.49 +/- 0.54) and length-for-age z score (LAZ) (-0.20 +/- 0.54) than did the NT group (WAZ: -0.67 +/- 0.54; LAZ: -0.39 +/- 0.54) and the NT and SP groups combined (WAZ: -0.65 +/- 0.54; LAZ: -0.38 +/- 0.54); the difference with the NI group (WAZ: -0.74 +/- 1.1; LAZ: -0.40 +/- 1.0) was not significant. A lower percentage of the NI infants (25%) than of the intervention groups (SP: 39%; NT: 36%; NB: 49%) could walk independently by 12 mo.
                All 3 supplements had positive effects on motor milestone acquisition by 12 mo compared with no intervention, but only NB affected growth. Diets of infants across the world are commonly deficient in multiple micronutrients during the period of growth faltering and dietary transition from milk to solid foods. A randomized placebo controlled trial was carried out in Indonesia, Peru, South Africa, and Vietnam, using a common protocol to investigate whether improving status for multiple micronutrients prevented growth faltering and anemia during infancy. The results of the pooled data analysis of the 4 countries for growth, anemia, and micronutrient status are reported. A total of 1134 infants were randomized to 4 treatment groups, with 283 receiving a daily placebo (P), 283 receiving a weekly multiple micronutrient supplement (WMM), 280 received a daily multiple micronutrient (DMM) supplement, and 288 received daily iron (DI) supplements. The DMM group had a significantly greater weight gain, growing at an average rate of 207 g/mo compared with 192 g/mo for the WMM group, and 186 g/mo for the DI and P groups. There were no differences in height gain. DMM was also the most effective treatment for controlling anemia and iron deficiency, besides improving zinc, retinol, tocopherol, and riboflavin status. DI supplementation alone increased zinc deficiency. The prevalence of multiple micronutrient deficiencies at baseline was high, with anemia affecting the majority, and was not fully controlled even after 6 mo of supplementation. These positive results indicate the need for larger effectiveness trials to examine how to deliver supplements at the program scale and to estimate cost benefits. Consideration should also be given to increasing the dosages of micronutrients being delivered in the foodlets. To determine the efficacy and cost-effectiveness of providing oral supplementation early in the course of malnutrition for hemodialysis (HD) patients.
                The study design consisted of 3 groups: an experimental group, a control group of patients with mild hypoalbuminemia (HA) (serum albumin [SA] = 3.5 to 3.7 g/dL), and a comparison group of patients with moderate to severe HA (SA = 2.5 to 3.4 g/dL).
                Ten outpatient hemodialysis centers in southeast lower Michigan.
                Treatment and control groups consisted of 32 HD patients with mild HA. Fourteen HD patients with moderate to severe HA comprised the comparison group.
                The experimental group received diet counseling and oral supplementation, and the control group received diet counseling only. The comparison group received physician-prescribed oral supplements and dietary counseling to permit comparison of the experimental treatment with current supplementation practices.
                Differences between groups in the number of patients reaching nutritional repletion, change in SA levels at the end of the study, and follow-up periods, were tested using chi-square analysis. Analysis of variance was used to compare group differences in treatment duration to repletion and number of hospitalization days.
                During the study period, significantly more patients reached nutritional repletion in the experimental group and control group (50% and 57%, respectively) than in the comparison group (7%). Overall, repletion occurred more quickly in the experimental group (3.2 +/- 1.7 months) than in the control group (3.5 +/- 1.2 months), with a larger number of patients in the experimental group repleted by month 2 of the study phase. During follow-up, patients in the experimental group were far more likely to maintain nutritional repletion or continue to improve (61%) than patients in the control group (14%). Although too few patients were hospitalized to show statistical significance, there was a trend toward greater numbers of hospital days in more malnourished patients (208 days for the comparison group), followed by those with mild HA who did not receive oral supplements (107 days), and the experimental group (71 days).
                Although the sample size for this study was too small for the results to be conclusive, it appears that use of nutritional supplements early in the course of malnutrition may provide benefits such as, attaining nutritional repletion more quickly, which results in less product usage. It is also more likely that good nutritional status will be maintained after supplementation is discontinued.
                Copyright 2001 by the National Kidney Foundation, Inc. Standard therapy for severe acute malnutrition (SAM) is home-based therapy with ready-to-use therapeutic food (RUTF) containing 25% milk. In an effort to lower the cost of RUTF and increase availability, some have suggested that a portion of milk be replaced with soy. This trial was designed to determine whether treating children with SAM with 10% milk RUTF containing soy would result in a similar recovery rate compared with the 25% milk RUTF. This was a randomized, double-blind, controlled, clinical, quasi-effectiveness trial of isoenergetic amounts of 2 locally produced RUTF to treat SAM in Malawi among children aged 6-59 mo. A total of 1874 children were enrolled. Children were assessed every fortnight and participated in the study until they clinically recovered or received 8 wk of treatment. The primary outcome was recovery (weight-for-height Z score > -2 and no edema). Secondary outcomes were rates of weight and height gain. Survival analysis was used to compare the recovery rates. Recovery among children receiving 25% milk RUTF was greater than children receiving 10% milk RUTF, 64% compared with 57% after 4 wk, and 84% compared with 81% after 8 wk (P < 0.001). Children receiving 25% milk RUTF also had higher rates of weight and height gain compared with children receiving 10% milk RUTF. Treating children with SAM with 10% milk RUTF is less effective compared with treatment with the standard 25% milk RUTF. These findings also emphasize that clinical evidence should be examined before recommending any changes to the formulation of RUTF.
In conclusion, there is moderate to high quality evidence that both lipid-based nutrient supplements and blended foods are effective in treating children with MAM. Although lipid-based nutrient supplements (LNS) led to a clinically significant benefit in the number of children recovered in comparison with blended foods, LNS did not reduce mortality, the risk of default or progression to SAM. It also induced more vomiting. Blended foods such as CSB++ may be equally effective and cheaper than LNS. Most of the research so far has focused on industrialised foods, and on short-term outcomes of MAM. There are no studies evaluating interventions to improve the quality of the home diet, an approach that should be evaluated in settings where food is available, and nutritional education and habits are the main determinants of malnutrition. There are no studies from Asia, where moderate acute malnutrition is most prevalent.