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Multicentre trial of oral calorie supplements for children with cystic fibrosis

Multicentre trial of oral calorie supplements for children with cystic fibrosis: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN95744468
Enrollment
97
Registered
2005-07-01
Start date
2000-07-01
Completion date
Unknown
Last updated
2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic fibrosis Nutritional, Metabolic, Endocrine Cystic fibrosis

Interventions

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 u

Sponsors

University of Liverpool (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Change in body mass index centile over one year.

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026