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primary studies published RCT

Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor for 24 Weeks or Longer in People with Cystic Fibrosis and One or More F508del Alleles: Interim Results of an Open-Label Phase 3 Clinical Trial.

  • Year: 2021
  • Date:
  • Author: Griese M
Source

Am J Respir Crit Care Med. 2021 Feb 1;203(3):381-385. doi: 10.1164/rccm.202008-3176LE.

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

Randomized controlled trial

Participants

Seventy children aged 6 months to 18 years with confirmed CF

Interventions

A structured Nutritional Intervention Package (NIP) vs Conventional Nutritional Counseling (CNC

Outcome measures

Nutritional status. The primary outcome was weight gain. Secondary outcomes included changes in height, head circumference, mid-upper arm circumference (MUAC), total skinfold thickness (TSF), and body mass index (BMI). Anthropometric measurements were assessed at baseline, three, and six months.

Main results

Both groups showed significant improvements in anthropometric measurements over time, particularly in terms of weight (F = 51.289, P < 0.001, η² = 0.43) and height (F = 136.600, P < 0.001, η² = 0.668). A trend towards greater improvements in head circumference and BMI was observed in the NIP group, although the difference was not statistically significant.

Authors' conclusions

These findings highlight the importance of structured nutritional interventions in CF management, regardless of the approach used. Future research should focus on long-term studies, personalized nutritional approaches, and strategies to improve adherence to nutritional regimens in children with CF.

Keywords: non pharmacological intervention - diet; non pharmacological intervention - psyco-soc-edu-org; Nutrition Disorders; Behavioural interventions; training; Counseling;