Effect of titrated parenteral nutrition on body composition after allogeneic hematopoietic stem cell transplantation in children: a double-blind, randomized, multicenter trial

Abstract

Background: Children undergoing hematopoietic stem cell transplantation (HSCT) often require parenteral nutrition (PN) to optimize caloric intake. Standard approaches to nutritional supplementation provide 130-150% of estimated energy expenditure, but resting energy expenditure (REE) may be lower than expected after HSCT. Provision of PN exceeding energy needs may lead to overfeeding and associated complications.

Objective: We conducted a blinded, randomized, controlled, multicenter trial in children undergoing HSCT to determine the effect on body composition of 2 different approaches of nutrition support: standard amounts of energy from PN (130-150% of REE) compared with PN titrated to match measured REE.

Design: Twenty-six children undergoing HSCT were randomly assigned to standard or titrated PN. Energy intake was monitored until day 30 after HSCT. Body-composition and anthropometric measures were obtained through day 100. The primary outcome variable was percentage body fat (%BF) measured by dual energy X-ray absorptiometry.

Results: The estimated change in %BF from baseline to day 30 was 1.2 ± 0.5% in the standard group and 0.1 ± 0.5% in the experimental group, but the overall time course of %BF did not differ significantly by treatment (P = 0.39 for time × treatment interaction). A profound loss of lean body mass (LBM) occurred in both groups during the intervention period and persisted through day 100.

Conclusions: Parenteral energy intake titrated to energy expenditure does not result in a lower accumulation of BF than does standard energy intake. Neither titrated nor standard PN regimens during HSCT preserve LBM. Alternative approaches to preserve LBM are needed. This trial is registered at clinicaltrials.gov as 00115258.

Trial registration: ClinicalTrials.gov NCT00115258.

FIGURE 1.

Flow diagram depicting enrollment, allocation, and follow-up of study participants. Two patients in the experimental group and 1 patient in the standard group did not ultimately require parenteral nutrition, but their data were nonetheless collected and included in an intention-to-treat analysis as if they had received the assigned treatment.

FIGURE 2.

Dietary intake immediately preceding transplant (study day 0) declined by ∼50%. Over 30 d of hospitalization after transplant, subjects randomly assigned to the standard nutrition protocol received nearly twice their REE, whereas those randomly assigned to the experimental protocol were maintained closely to caloric requirements. Data are represented as unadjusted means ± SEs; n = 12–13 subjects per treatment group on each day through day 20, then 5–12 per group through day 30. Linear spline analysis indicated that the time course for the 2 treatment groups diverged significantly for both total caloric intake (upper panel; P = 0.007) and excess over REE (lower panel; P < 0.0001). REE, resting energy expenditure.

FIGURE 3.

Change in percentage body fat from transplant (baseline) through hospitalization (day 30) and follow-up (day 100). Data are represented as means ± SEs adjusted for age, sex, and type of donor; n = 13 subjects in each treatment group at baseline, 12 standard and 11 experimental subjects at day 30, and 9 standard and 12 experimental subjects at day 100. Repeated-measures ANOVA indicated no significant difference in time course between treatments (P = 0.39 for time × treatment interaction).