Related Experiment Video
Updated: Aug 11, 2026
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Oral protein energy supplements for children with cystic fibrosis: CALICO multicentre randomised controlled trial
Vanessa J Poustie1, Jayne E Russell, Ruth M Watling
1University of Liverpool Division of Child Health, Royal Liverpool Children's Hospital, Liverpool L12 2AP.
Insights
Long-term oral protein energy supplements did not improve nutritional status in moderately malnourished children with cystic fibrosis. These supplements are not essential for managing this patient group.
Area of Science:
- Pediatric Nutrition
- Cystic Fibrosis Management
- Clinical Trial Research
Background:
- Cystic Fibrosis (CF) is a genetic disorder affecting multiple organs, often leading to malnutrition.
- Moderate malnutrition is a common challenge in children with CF, impacting growth and overall health.
- Oral protein energy supplements are sometimes used to address nutritional deficits in pediatric CF patients.
Purpose of the Study:
- To evaluate the efficacy of long-term oral protein energy supplements in moderately malnourished children with cystic fibrosis.
- To determine if supplementation improves nutritional status, body mass index (BMI), and other clinical outcomes.
- To assess the necessity of these supplements in the standard management of pediatric CF.
Main Methods:
- A multicentre randomized controlled trial involving 102 children (aged 2-15 years) with moderate malnutrition due to CF.
- Participants received either oral protein energy supplements plus usual dietary advice or dietary advice alone for 12 months.
- The primary outcome measure was the change in body mass index (BMI) centile over the one-year study period.
Main Results:
- Supplementation showed no significant association with changes in BMI centile (mean difference 2.99 centile points; 95% CI -2.70 to 8.68).
- No improvements were observed in other nutritional markers or spirometric outcomes in the supplemented group.
- The study found no statistically significant benefit of oral protein energy supplements in this cohort.
Conclusions:
- Long-term oral protein energy supplementation does not enhance nutritional status or clinical outcomes in moderately malnourished children with cystic fibrosis.
- These supplements should not be considered a mandatory component of care for this specific patient population.
- Further research may explore alternative or adjunctive nutritional strategies for pediatric CF patients with malnutrition.
Objective:
To determine whether oral protein energy supplements, used long term in children with cystic fibrosis who are moderately malnourished, improve nutritional and other outcomes.
Design:
Multicentre randomised controlled trial.
Setting:
Seven specialist paediatric cystic fibrosis centres and their associated shared care clinics and seven smaller paediatric cystic fibrosis clinics.
Participants:
102 children with cystic fibrosis, aged between 2 and 15 years, who were moderately malnourished.
Interventions:
Oral protein energy supplements in addition to usual dietary advice compared with dietary advice alone, for 12 months.
Main Outcome Measure:
Change in body mass index centile over one year.
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.
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.
Trial Registration:
ISRCTN: 95744468.
