Jackson, L., Cohen, J. orcid.org/0000-0002-1538-3521, Sully, B. et al. (1 more author) (2015) NOURISH, Nutritional OUtcomes from a Randomised Investigation of Intradialytic oral nutritional Supplements in patients receiving Haemodialysis: a pilot randomised controlled trial. Pilot and Feasibility Studies, 1 (11).
Abstract
Background The study was done to assess the feasibility of conducting a trial evaluating the use of an intradialytic oral nutritional supplement (ONS) on nutritional status.
Methods The study design is a single centre, parallel group, external pilot randomised controlled trial (RCT). The setting was at a haemodialysis unit in Sheffield, UK. The aim was to recruit 30 trial participants to allow at least 12 evaluable patients per arm, but the actual study sample consisted of 10 adults with a body mass index (BMI) ≤22 kg/m2, receiving thrice weekly haemodialysis. All participants received nutritional advice from a renal dietitian as per usual practice. The intervention included the provision of an intradialytic ONS. Feasibility outcomes included recruitment to time and retention of participants along with palatability of ONS. Secondary outcomes were clinical parameters to obtain variance and estimates of effect size to inform the sample size calculation for a definitive trial.
Results Recruitment was undertaken for a fixed period of 6 weeks. Rates were lower than expected mainly due to ineligibility with only 7% of screened patients (19/265) being eligible and 4% (10/265) of these being recruited. Due to the small proportion of patients eligible for the trial, all haemodialysis patients at the specified unit were assessed for eligibility. Data completion rates were low for session questionnaires (23%). Sample sizes derived from variance in secondary outcome measure of handgrip strength and adjusted for a dropout rate of 20% indicate that 189 patients would be required for a definitive RCT, requiring 19 UK haemodialysis units to participate.
Conclusions A definitive RCT is feasible with some adaptation to exclusion criteria and methodology. The exclusion criteria could be adapted to include an increase in upper limit for BMI. The use of questionnaires at each dialysis session may not be feasible but the inclusion of appetite and supplement consumption data collection at the main assessments would provide similar outcome data. Quality of life assessment using SF-12 would be acceptable.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2015 Jackson et al.; licensee BioMed Central. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
Keywords: | Nutritional supplements; Haemodialysis; Quality of life; Handgrip |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Health and Related Research (Sheffield) > ScHARR - Sheffield Centre for Health and Related Research |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 22 Mar 2017 16:05 |
Last Modified: | 23 Jun 2023 22:24 |
Published Version: | https://doi.org/10.1186/s40814-015-0007-1 |
Status: | Published |
Publisher: | BioMed Central |
Refereed: | Yes |
Identification Number: | 10.1186/s40814-015-0007-1 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:112604 |