Oral protein energy supplements for children with cystic fibrosis: CALICO multicentre randomised controlled trial

doi:10.1136/bmj.38737.600880.AE

BMJ 2006;332:632-636 (18 March), doi:10.1136/bmj.38737.600880.AE (published 8 February 2006)

Research

Oral protein energy supplements for children with cystic fibrosis: CALICO multicentre randomised controlled trial

Vanessa J Poustie, research associate¹, Jayne E Russell, research assistant¹, Ruth M Watling, chief dietician², Deborah Ashby, professor of medical statistics³, Rosalind L Smyth, professor¹, CALICO Trial Collaborative Group

¹ University of Liverpool Division of Child Health, Royal Liverpool Children's Hospital, Liverpool L12 2AP, ² Department of Nutrition and Dietetics, Royal Liverpool Children's Hospital, ³ Wolfson Institute of Preventive Medicine, Queen Mary, University of London

Correspondence to: R L Smyth r.l.smyth{at}liv.ac.uk

Abstract

Objective To determine whether oral protein energy supplements,used long term in children with cystic fibrosis who are moderatelymalnourished, improve nutritional and other outcomes.

Design Multicentre randomised controlled trial. Setting Sevenspecialist paediatric cystic fibrosis centres and their associatedshared care clinics and seven smaller paediatric cystic fibrosisclinics.

Participants 102 children with cystic fibrosis, aged between2 and 15 years, who were moderately malnourished.

Interventions Oral protein energy supplements in addition tousual dietary advice compared with dietary advice alone, for12 months.

Main outcome measure Change in body mass index centile overone year.

Results Use of supplements was not associated with a changein body mass index centile (mean difference 2.99 centile points,95% confidence interval -2.70 to 8.68) or other nutritionaland spirometric outcomes in this group of children.

Conclusions Long term use of oral protein energy supplementsdid not result in an improvement in nutritional status or otherclinical outcomes in children with cystic fibrosis who weremoderately malnourished. Oral protein energy supplements shouldnot be regarded as an essential part of the management of thisgroup of children.

Trial registration ISRCTN: 95744468.

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