Feasibility of Consumption of Nutritional Supplementation in Primary Ciliary Dyskinesia ((PCD))
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ClinicalTrials.gov Identifier: NCT06028607 |
Recruitment Status :
Completed
First Posted : September 8, 2023
Last Update Posted : September 13, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | August 24, 2023 | ||||
First Posted Date ICMJE | September 8, 2023 | ||||
Last Update Posted Date | September 13, 2023 | ||||
Actual Study Start Date ICMJE | May 17, 2021 | ||||
Actual Primary Completion Date | November 29, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Feasibility of Consumption of Nutritional Supplementation in Primary Ciliary Dyskinesia | ||||
Official Title ICMJE | 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 | ||||
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. |
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Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: All service users will be approached for inclusion in feasibility Masking: None (Open Label)Primary Purpose: Other |
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Condition ICMJE | Primary Ciliary Dyskinesia | ||||
Intervention ICMJE | Dietary Supplement: QD-27
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
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Study Arms ICMJE | Study Population
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. Intervention: Dietary Supplement: QD-27
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
15 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | February 28, 2022 | ||||
Actual Primary Completion Date | November 29, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 17 Years and older (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United Kingdom | ||||
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Administrative Information | |||||
NCT Number ICMJE | NCT06028607 | ||||
Other Study ID Numbers ICMJE | Version 1.0 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Professor Daniel G Peckham, University of Leeds | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | University of Leeds | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | University of Leeds | ||||
Verification Date | September 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |