Oral protein energy supplements for children with cystic fibrosis: CALICO multicentre randomised controlled trial.
OBJECTIVE
To determine whether oral protein energy supplements, used long term in children with cystic fibrosis who are moderately malnourished, improve nutritional and other outcomes.


METHODS
Multicentre randomised controlled trial.


METHODS
Seven specialist paediatric cystic fibrosis centres and their associated shared care clinics and seven smaller paediatric cystic fibrosis clinics.


METHODS
102 children with cystic fibrosis, aged between 2 and 15 years, who were moderately malnourished.


METHODS
Oral protein energy supplements in addition to usual dietary advice compared with dietary advice alone, for 12 months.


METHODS
Change in body mass index centile over one year.


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


CONCLUSIONS
Long term use of oral protein energy supplements did not result in an improvement in nutritional status or other clinical outcomes in children with cystic fibrosis who were moderately malnourished. Oral protein energy supplements should not be regarded as an essential part of the management of this group of children.


BACKGROUND
ISRCTN: 95744468.
Poustie
Vanessa J
VJ
University of Liverpool Division of Child Health, Royal Liverpool Children's Hospital, Liverpool L12 2AP.
Russell
Jayne E
JE
Watling
Ruth M
RM
Ashby
Deborah
D
Smyth
Rosalind L
RL
D000284:Administration, Oral; D000293:Adolescent; D015992:Body Mass Index; D002648:Child; D002675:Child, Preschool; D003550:Cystic Fibrosis / Q000178:diet therapy*; D004044:Dietary Proteins / Q000008:administration & dosage*; D019587:Dietary Supplements; D002149:Energy Intake; D006801:Humans; D011502:Protein-Energy Malnutrition / Q000178:diet therapy
D004044:Dietary Proteins