Feasibility of consumption of nutritional supplements in PCD

• Research type

  Research Study

• Full title

  A study to explore the feasibility of consumption of essential complex amino acid supplementation in the form of an oral gel with additional leucine (40%) and vitamin D in patients with Primary Ciliary Dyskinesia: a feasibility study.

• IRAS ID

  222335

• Contact name

  Jean Uniacke

• Contact email

  governance-ethics@leeds.ac.uk

• Sponsor organisation

  University of Leeds

• Clinicaltrials.gov Identifier

  NCT06028607

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  This study aims to explore the feasibility of consumption of a specific amino acid oral nutritional supplementation gel (2 per day) containing 7.5g of essential amino acids (40% leucine) and 500 IU/d vitamin D (daily total 15g essential amino acids and 1000 IU vitamin D) over a 3 month period using validated feasibility/tolerability assessment measures and impact upon nutritional intake through 24 hour recalls alongside establishing habitual activity estimation scales in participants with primary Ciliary Dyskinesia. The supplements will be taken alongside 2 meals (breakfast and lunch) as these tend to be sub optimal in protein intake to enhance the effects. This is based on initial pilot data showing no impact on intake in healthy older adults.
  
  Secondary outcomes will explore the feasibility of collecting routine measures (lung function (FEV1%), number of exacerbation's during study period, vitamin D status), additional body composition measurements via Bio impedance analysis(BIA), skin-fold measures (e.g. Tricep Skin-fold (TSF), Mid upper arm circumference (MUAC))and handgrip strength using Handgrip dynamometer in patients who attend for their annual check up clinic and an additional study specific visit.
  This study will also explore feasibility of collecting quality of life impact through validated questionnaire and establish affect on exercise tolerance through 6 minute walking tests at baseline (routine appointment) and 3 months (study specific visit).
  These secondary outcomes are required to enable understanding of engagement from participants and to identify possible important outcome measures that may need further exploration through future clinical trials.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  20/SC/0413

• Date of REC Opinion

  24 Dec 2020

• REC opinion

  Further Information Favourable Opinion