Multicentre trial of oral calorie supplements for children with cystic fibrosis
Not Applicable
Completed
- Conditions
- Cystic fibrosisNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN95744468
- Lead Sponsor
- niversity of Liverpool (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 97
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in body mass index centile over one year.
- Secondary Outcome Measures
Name Time Method Other nutritional outcomes, spirometry outcomes, eating behaviour, activity levels, gastrointestinal symptoms.