evidence-based blog of Filippo Dibari

Posts Tagged ‘clinical trial’

Impact of lipid-based nutrient supplements and corn-soy blend on energy and nutrient intake among moderately underweight 8-18-month-old children participating in a clinical trial

In Under-nutrition on November 7, 2014 at 6:08 pm

by Thakwalakwa CM, Ashorn P, Phuka JC, Cheung YB, Briend A, Maleta KM

from Matern Child Nutr. 2014 Feb 17

 

Abstract

Nutrition interventions have an effect on growth, energy and nutrient intake, and development, but there are mixed reports on the effect of supplementation of energy-dense foods on dietary intake.

This substudy aimed at assessing the effect of supplementation with corn-soy blend (CSB) or lipid-based nutrient supplement (LNS) on energy and nutrient intake in moderately underweight children participating in a clinical trial. A total of 188 children aged 8-18 months participated and received daily either 284 kcal from CSB or 220 kcal from LNS and no supplements (control).

An interactive 24-h recall method was used to estimate energy and nutrient intakes in the groups. Total mean energy intake was 548 kcal, 551 kcal and 692 kcal in the control, CSB and LNS groups, respectively (P = 0.011). The mean (95% confidence interval) intake of energy and protein were 144 (37-250; P < 0.001) and 46 (1.5-7.6; P < 0.001) larger, respectively, in the LNS group than among the controls. No significant differences were observed between the control and CSB groups. Energy intake from non-supplement foods was significantly lower in the CSB group compared with the control group, but not in the LNS group, suggesting a lower displacement of non-supplement foods with LNS. Both CSB and LNS supplementation resulted in higher intakes of calcium, iron, zinc and vitamin C compared with controls (all P ≤ 0.001).

This study indicates that LNS might be superior to CSB to supplement underweight children as it results in higher energy intake, but this requires confirmation in other settings.

Nutritional support for African adults starting antiretroviral therapy (NUSTART) – a clinical trial

In Under-nutrition on May 5, 2012 at 2:37 pm

Background of the Trial. Micronutrient deficiencies and altered mineral metabolism associated with wasting malnutrition are potential risk factors for death among African patients referred for anti‐retroviral therapy (ART). We will conduct a randomized controlled phase III trial of a lipid‐based nutrient supplement (LNS)* without or with vitamins and bulk minerals during the first weeks after referral for ART.

* Also known as lipid-based, ready-to-use food for nutrition rehabilitation.

“A number of important universities is conducting an interesting randomized controlled clinical trial to test a lipid-base, ready-to-use food in adults, ART naive, with BMI < 18.5 kg/m2, requiring ART as determined by CD4 count < 350/l. The primary outcome consists of survival from the time of referral for ART to 12 weeks after starting ART, whereas the secondary outcomes are hospitalization from referral for ART to 12 weeks after starting ART, gain in lean body mass, and change in serum phosphate.

“All participants will receive a stepped regimen of LNS: this comprises a small daily dose of LNS (SDLNS) containing limited calories, from time of referral for ART through the pre‐ART preparation phase and until 2 weeks after start of ART, and then a larger daily dose of LNS containing a greater calorie provision (LD‐LNS) for four weeks, i.e., from 2 to 6 weeks after start of ART.

“The investigators are: Professor Suzanne Filteau (principal investigator), London School of Hygiene & Tropical Medicine; Professor Henrik Friis, University of Copenhagen; Dr Paul Kelly, Barts & The London School of Medicine and University Teaching Hospital, Lusaka; Dr Lackson Kasonka, University Teaching Hospital, Lusaka; Mr John Changalucha, Mwanza Medical Research Centre, Tanzania; Dr. Tsinuel Girma. Jimma University Specialised Hospital, Ethiopia; Dr. Douglas Heimburger, Vanderbilt University, USA; Dr. Aase Bengaard Andersen, University of Odense, Denmark; Dr. John Koethe, Vanderbilt University, USA.”

More informations are available on this document.

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