Nutritional outcomes for a randomised investigation of nutritional supplements in patients who receive haemodialysis
ISRCTN | ISRCTN37431579 |
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DOI | https://doi.org/10.1186/ISRCTN37431579 |
Secondary identifying numbers | 001 |
- Submission date
- 12/03/2013
- Registration date
- 09/04/2013
- Last edited
- 30/03/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Haemodialysis is a form of renal replacement therapy that clears the blood of toxins when a persons own kidneys are unable to do so. The haemodialysis process unfortunately also filters out the building blocks of protein and uses energy. Patients with kidney disease often have a poor appetite and limited dietary intake because of their kidney problems and this in combination with the effects of haemodialysis can lead to the development of malnutrition. Studies have shown between 20% and 50% of haemodialysis patients to be malnourished and malnutrition can worsen clinical outcomes and increase the risk of hospitalisation. This is an initial study to assess the use of an intradialytic (meaning whilst on haemodialysis) nutritional supplement on nutritional status and whether this works better than normal care.
Who can participate?
Participants must be over the age of 18, receive regular haemodialysis and have a measure of height for weight that is lower than advised for a person receiving haemodialysis.
What does the study involve?
Participants are randomly allocated to one of two groups: an intervention and a control group. The intervention group will take a nutritional supplement each dialysis session from a choice of drinks or puddings in various flavours. The control group will receive standard care.
Each group will complete a short questionnaire about their wellbeing each time they attend haemodialysis. They will have their hand grip strength measured and fill in a Quality Of Life questionnaire, at the start and at 1 and 2 months. Their weight will also be recorded along with routine blood tests.
What are the possible benefits and risks of participating?
There may not be any benefit to the participants directly, in part due to the study being of very short duration but the results of the study may help to improve the nutritional wellbeing of people receiving haemodialysis in the future.
The risks to people who participate are very small as nutritional supplements are routinely used with people who have kidney problems.
Where is the study run from?
The trial will be conducted on one haemodialysis unit in a Yorkshire hospital (UK).
When is the study starting and how long is it expected to run for?
The study will run between May and September 2013.
Who is funding the study?
The University of Sheffield (UK)
Who is the main contact?
Louise Jackson, Senior Renal Dietitian
louise.jackson@sth.nhs.uk
Contact information
Scientific
Dietetic Department
Old Nurses Home
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
Study information
Study design | Single centre two-arm parallel group randomised controlled pilot trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Quality of life |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Nutritional OUtcomes from a Randomised Investigation of intradialytic oral nutritional Supplements in patients receiving Haemodialysis |
Study acronym | NOURISH |
Study objectives | The rationale for this trial is to assess the efficacy of oral nutritional supplements on nutritional status if provided whilst participants receive haemodialysis. Nutritional status will be measured using a variety of indicators. However, this is a feasibility trial that primarily aims to assess recruitment and retention of participants, delivery and acceptability of the intervention, data collection and completion rates along with analysis of results. |
Ethics approval(s) | NRES Committee Yorkshire & The Humber - Leeds East. REC reference: 13/YH/0092. IRAS project ID: 121918. Approval dated 15/04/13. |
Health condition(s) or problem(s) studied | Haemodialysis - a form of renal replacement therapy |
Intervention | Oral nutritional supplements versus standard care in haemodialysis patients An oral nutritional supplement will be provided to the intervention group each dialysis session for 2 months. A quality of life assessment, dietary interview and handgrip strength will be collected at baseline, 1 month and completion of the study (month 2) on both the intervention and control groups. The control group will continue to receive standard care but not the oral nutritional supplement. |
Intervention type | Supplement |
Primary outcome measure | 1. Recruitment rate, refusal, withdrawal and dropout rate 2. Barriers to recruitment 3. The ability to provide the intervention as per protocol 4. Palatability and preference for types of oral nutritional supplements 5. The feasibility, acceptability and appropriateness of data collection methods 6. Data completion rates |
Secondary outcome measures | The secondary outcomes relate to the efficacy of intradialytic nutritional supplementation on nutritional status. These parameters will help determine the most appropriate outcome measures and timing of data collection points for a larger RCT. Measures are: 1. Handgrip dynamometry 2. Quality of Life 3. Weight 4. Dietary intake |
Overall study start date | 01/05/2013 |
Completion date | 30/09/2013 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 30 |
Key inclusion criteria | 1. Adult male or female haemodialysis patients 2. Received maintenance haemodialysis for at least 6 months 3. Receives haemodialysis at least 3 times per week 4. Has a body mass index of 22kg/m2 or less |
Key exclusion criteria | 1. Amputees 2. Those with significant oedema 3. Patients who are unable to communicate fluently in English 4. Those receiving nutritional supplementation prior to the study commencing or within 1 month of starting the study 5. Those with persistent hyperkalaemia or hyperphosphataemia |
Date of first enrolment | 01/05/2013 |
Date of final enrolment | 30/09/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
S5 7AU
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Anna Leesley
Research and Development Department
11 Broomfield Road
Sheffield
S10 2SE
England
United Kingdom
https://ror.org/018hjpz25 |
Funders
Funder type
University/education
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Protocol article | protocol | 07/10/2013 | Yes | No | |
Results article | results | 01/12/2015 | Yes | No | |
HRA research summary | 28/06/2023 | No | No |