Feasibility of Consumption of Nutritional Supplementation in Primary Ciliary Dyskinesia

NCT06028607 | Completed

• 1 other identifier: Version 1.0
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Ciliary Dyskinesia

Outcome Measures

Primary Outcomes (3)

• Percentage consumption of supplement gels

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

  3 months

• Assessment of palatability of supplement gels

  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 months

• Measurement of dietary intake

  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

  3 months

Secondary Outcomes (15)

• Lung Function (Forced Expiratory Volume1 %, Forced Vital Capacity %)

  3 months

• Body Mass Index

  3 months

• Medical Research Council (MRC) breathlessness score

  3 months

• Vitamin D levels

  3 months

• Number of infections over study period

  3 months

Study Arms (1)

Study Population

OTHER

Participants will be recruited and consented as part of routine care. All will trial supplement initially and have standard and additional measures taken. they will be followed up at month 1 and 2 collecting the primary outcomes (acceptability/palatability and dietary intake) and all initial measures repeated at month 3. Each participant will receive 3 months supply of gels to consume 2 per day.

Dietary Supplement: QD-27

Interventions

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

Study Population

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LS2 9NL, United Kingdom

Location

Related Publications (2)

• Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. doi: 10.1097/00007632-200012150-00008. No abstract available.

  PMID: 11124729 BACKGROUND

• Jones PW, Quirk FH, Baveystock CM. The St George's Respiratory Questionnaire. Respir Med. 1991 Sep;85 Suppl B:25-31; discussion 33-7. doi: 10.1016/s0954-6111(06)80166-6.

  PMID: 1759018 BACKGROUND

MeSH Terms

Conditions

Ciliary Motility Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Daniel G Peckham

  Univeristy Of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Respiratory Medicine

Model Details: All service users will be approached for inclusion in feasibility

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 8, 2023
• Study Start: May 17, 2021
• Primary Completion: November 29, 2021
• Study Completion: February 28, 2022
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)