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Completed

NCT Number: NCT06028607

Feasibility of Consumption of Nutritional Supplementation in Primary Ciliary Dyskinesia

Feasibility study to understand and gain preliminary information on tolerability and palatability of an oral nutritional supplement gel in a clinical Primary Ciliary Dyskinesia population. To determine if dietary intake is affected by the consumption of the nutritional supplement.

Explore possible future outcome measures that could be important in determining impact of this nutritional intervention on this patient group.

Participants will be provided with the gel supplements and alongside will have other standard and non standard care measures assessed lung function (FEV1%) number of exacerbation's during study period vitamin D status Bio impedance analysis (BIA) skin-fold measures (e.g. Tricep Skin-fold (TSF) Mid upper arm circumference (MUAC) Handgrip strength (HGS) quality of life measures 6-minute walking tests. Hypothesis Patients with PCD can successfully consume 2 gel supplements per day for a period of 3 months with no effect on dietary intake.

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Key information

Conditions

Primary Ciliary Dyskinesia Abnormalities, Multiple Ciliary Motility Disorders Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Otorhinolaryngologic Diseases Respiratory Tract Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Leeds

Leeds, West Yorkshire, LS2 9NL, United Kingdom

About this study

This is a single site study taking place in a regional PCD clinic. Participants are screened via patient online data system by lead consultants and contacted via telephone to outline study and provide information and contact for queries. participant information sheet and pre-test guidance to be sent to participant prior to next scheduled clinic appointment.

Participants attend their usual clinic appointments where routine care measures are completed by healthcare assistants and lead consultants. They then have opportunity to ask study coordinator any questions and complete consent for additional measures to be recorded.

This is followed by a trial of the supplement to check for immediate tolerance followed by completion of consent to partake in study and initial palatability and acceptability records.

3 month supply of supplement is provided along with storage and consumption instructions (consume 1 at breakfast and 1 at lunch) a waste box to retain consumed sachets and record time of consumption. Additional telephone appointment made for 1 month to collect further palatability and acceptability along with dietary 24 hour recall.

Participant is contacted via telephone at month 1 and 2 to recheck tolerability, acceptability, palatability and dietary intake. Participant can withdraw at any time if unable to continue to tolerate gel supplement.

Participant returns to clinic at month 3 to repeat all standard measures, additional outcomes and palatability, acceptability and dietary intake.

participant has completed study offered further dietary support through usual clinic route with registered dietitian.

Participants can withdraw from the study at any point without giving any reason. Any data collected from them up until that point can be used in analysis.

As this is a feasibility study a sample size calculation is not required. The PCD population within the regional clinic at time of recruitment is 54. All patients with PCD will be approached for inclusion in this feasibility if they meet the inclusion criteria until minimum number of 15 and maximum of 20 is reached.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • People aged 17 or over with a confirmed diagnosis of Primary ciliary dyskinesia PCD (nasal brushings)
  • People who attend the Leeds Regional PCD Clinics
  • People who have capacity to give informed consent

Exclusion criteria

  • People who are pregnant
  • Those with existing co-morbidities such as malignancy
  • People with connective tissue disorders and immunoglobulin deficiencies
  • People with renal insufficiency r

Treatment and study plan

QD-27

Dietary Supplement

Oral Protein gel with greater Leucine proportion and vitamin D Consumption of 2 each day for 3 months to be taken at breakfast and lunch

Primary outcomes

  1. Percentage consumption of supplement gels

    Time frame: 3 months

    To measure through percentage (%) consumed by return of empty sachets over period of three months for each participant

  2. Assessment of palatability of supplement gels

    Time frame: 3 months

    To measure using hedonic rating scale (like a lot, like a little, neither like nor dislike, dislike a little, dislike a lot) the appearance, aroma, taste, sweetness, texture mouth feel over the study period of 3 months for each participant

  3. Measurement of dietary intake

    Time frame: 3 months

    To collect dietary intake at monthly intervals (baseline, one, two and three) using multiple pass 24 hour recalls conducted through face to face and telephone interviews at each time point recording all food and drink consumption. This is then analysed via Nutritics software, for each participant

Secondary outcomes

  1. Lung Function (Forced Expiratory Volume1 %, Forced Vital Capacity %)

    Time frame: 3 months

    Determine if any changes occur during 3-month period of supplementation

  2. Body Mass Index

    Time frame: 3 months

    Weight and height will be combined to report BMI in kg/m2

  3. Medical Research Council (MRC) breathlessness score

    Time frame: 3 months

    Will be assessed at initial and end points using the degree of breathlessness related activity. Scale is 1-5 (not troubled by breathless except on strenuous exercise to too breathless to leave the house or breathless when dressing and undressing) therefore the higher the score the worse the outcome

  4. Vitamin D levels

    Time frame: 3 months

    To determine any changes during supplementation period

  5. Number of infections over study period

    Time frame: 3 months

    Recorded as part of routine care the number of infections requiring antibiotic treatment either intravenous or oral) over the study period

  6. Quality of life outcome SF-36 questionnaire

    Time frame: 3 months

    Completion of SF-36 quality of life questionnaire questionnaire which is used to determine generic health concepts of functional status and wellbeing. Completed at baseline and end of study period. The higher the score the better the health outcomes

  7. Quality of Life outcome St Georges Respiratory Questionnaire

    Time frame: 3 months

    Completion of St Georges Respiratory questionnaire designed to measure health impairment in respiratory conditions. The results are calculated out of 100 with 100 being the worst possible outcomes and 0 the best.

  8. Habitual activity estimation scale (HAES)

    Time frame: 3 months

    HAES scale which establishes daily activity levels at baseline and end of study for one typical weekday and one typical weekend day and using percentage of time spent on those activities out of 100%.

  9. Hand grip strength dynamometry

    Time frame: 3 months

    Measurement of muscle functionality using hand grip dynamometer recorded as kg/f (kilograms of force)

  10. Tricep skinfold measure

    Time frame: 3 months

    To determine any changes during supplementation period. Measured in millimetres using Harpenden skinfold calipers

  11. Mid upper arm circumference

    Time frame: 3 months

    To determine any changes during supplementation period measured in centimetres, measured using an identified mid point between the acromion and olecranon processes using a tape measure

  12. Six minute walk tests

    Time frame: 3 months

    To determine any changes during supplementation period

  13. Bio electrical impedance analysis

    Time frame: 3 months

    Measure the electrical resistance of tissue to determine skeletal muscle mass reported as percentages and kilograms of participants at baseline and end point

  14. Bio electrical impedance analysis

    Time frame: 3 months

    Measure the electrical resistance of tissue to determine fat mass (FM), reported as percentages and kilograms of participants at baseline and end point

  15. Bio electrical impedance analysis

    Time frame: 3 months

    Measure the electrical resistance of tissue to determine fat free mass (FFM) reported as percentages and kilograms of participants at baseline and end point

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Registry information

Official study title

A Study to Explore the Feasibility of Consumption of Specific 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

Acronym: (PCD)

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 8, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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