Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/06/2005
Date assigned
01/07/2005
Last edited
28/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Rosalind Smyth

ORCID ID

Contact details

Institute of Child Health
Royal Liverpool Children's Hospital
Alder Hey
Liverpool
L122AP
United Kingdom
+44 (0)151 252 5693
r.l.smyth@liv.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PJ484

Study information

Scientific title

Acronym

CALICO

Study hypothesis

Oral calorie supplements improve, or prevent deterioration in, body mass index centile of children with cystic fibrosis.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Oral protein energy supplements

Primary outcome measures

Change in body mass index centile over one year.

Secondary outcome measures

Other nutritional outcomes, spirometry outcomes, eating behaviour, activity levels, gastrointestinal symptoms.

Overall trial start date

01/07/2000

Overall trial end date

01/10/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

97

Participant 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.

Recruitment start date

01/07/2000

Recruitment end date

01/10/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Child Health
Liverpool
L122AP
United Kingdom

Sponsor information

Organisation

University of Liverpool (UK)

Sponsor details

Brownlow Hill
Liverpool
L69 3BX
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

UK Cystic Fibrosis Trust research grant (Ref PJ484)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16467348

Publication citations

  1. Results

    Poustie VJ, Russell JE, Watling RM, Ashby D, Smyth RL, , Oral protein energy supplements for children with cystic fibrosis: CALICO multicentre randomised controlled trial., BMJ, 2006, 332, 7542, 632-636, doi: 10.1136/bmj.38737.600880.AE.

Additional files

Editorial Notes