CFDB - Cystic Fibrosis DataBase

primary studies published RCT

Oral protein energy supplements for children with cystic fibrosis: CALICO multicentre randomised controlled trial.

Study design (if review, criteria of inclusion for studies)

Multicentre randomised controlled trial. Parallel design

Participants

102 children aged 2 - 15 years with CF and at least one of the following criteria: BMI < 25th centile but > 0.4th centile; or no increase in weight over the previous 3 months; or 5% decrease in weight from baseline over a period of < 6 months

Interventions

Oral calorie supplements compared with dietary advice

Outcome measures

Change in weight Change in height Gastrointestinal symptoms Change in BMI Change in BMI percentile Mid-upper arm circumference Energy and macro-nutrient intake FEV1 and FVC expressed as % predicted for age, sex and height Change in weight percentile Change in height percentile

Main 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.

Authors' 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

Keywords: Adolescent; Caloric Intake; Child; non pharmacological intervention - diet; Oral; Proteins; Supplementation; Malnutrition; Nutrition Disorders;