Multicentre trial of oral calorie supplements for children with cystic fibrosis

ISRCTN	ISRCTN95744468
DOI	https://doi.org/10.1186/ISRCTN95744468
Protocol serial number	PJ484
Sponsor	University of Liverpool (UK)
Funder	UK Cystic Fibrosis Trust research grant (Ref PJ484)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Rosalind Smyth
Scientific

Institute of Child Health
Royal Liverpool Children's Hospital
Alder Hey
Liverpool
L122AP
United Kingdom

Phone	+44 (0)151 252 5693
Email	r.l.smyth@liv.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Multicentre trial of oral calorie supplements for children with cystic fibrosis: a randomised controlled trial
Study acronym	CALICO
Study objectives	Oral calorie supplements improve, or prevent deterioration in, body mass index centile of children with cystic fibrosis.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cystic fibrosis
Intervention	Oral protein energy supplements. The control intervention involved routine dietary advice provided by the cystic fibrosis clinic dietitians, who advised on improving nutritional content of the diet using normal foods, ie not prescribing oral protein, energy supplements. The treatment group received these supplements in addition to routine dietary advice.
Intervention type	Supplement
Primary outcome measure(s)	Change in body mass index centile over one year.
Key secondary outcome measure(s)	Other nutritional outcomes, spirometry outcomes, eating behaviour, activity levels, gastrointestinal symptoms.
Completion date	01/10/2005

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Years
Upper age limit	15 Years
Sex	All
Target sample size at registration	97
Key inclusion criteria	Children with cystic fibrosis aged between 2-15 years who meet one of the following criteria: 1. Body mass index centile of less than 25th and more than 0.4th for age 2. No increase in body weight over the past 3 months 3. Decrease in body weight of 5% from baseline over a period of less than six months
Key exclusion criteria	Children were excluded if they had been diagnosed with cystic fibrosis in the previous three months, had received any form of enteral nutrition during the previous three months, had cystic fibrosis-related diabetes or liver disease, or had a forced expiratory volume at one second (FEV1) of less than 30% of that predicted for height, age and sex.
Date of first enrolment	01/07/2000
Date of final enrolment	01/10/2005

Institute of Child Health

Liverpool
L12 2AP
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	18/03/2006		Yes	No

03/10/2017: internal review.