Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
001
Study information
Scientific title
Nutritional OUtcomes from a Randomised Investigation of intradialytic oral nutritional Supplements in patients receiving Haemodialysis
Acronym
NOURISH
Study hypothesis
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
NRES Committee Yorkshire & The Humber - Leeds East. REC reference: 13/YH/0092. IRAS project ID: 121918. Approval dated 15/04/13.
Study design
Single centre two-arm parallel group randomised controlled pilot trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Nutritional supplements
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 trial start date
01/05/2013
Overall trial end date
30/09/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant 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
Recruitment start date
01/05/2013
Recruitment end date
30/09/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dietetic Department
Sheffield
S5 7AU
United Kingdom
Funders
Funder type
University/education
Funder name
University of Sheffield (UK) - Student Thesis as part of a Masters in Clinical Research
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24156091
2015 results in: http://www.pilotfeasibilitystudies.com/content/1/1/11/abstract
Publication citations
-
Protocol
Jackson L, Sully B, Cohen J, Julious S, Nutritional outcomes from a randomised investigation of intradialytic oral nutritional supplements in patients receiving haemodialysis, (NOURISH): a protocol for a pilot randomised controlled trial., Springerplus, 2013, 2, 515, doi: 10.1186/2193-1801-2-515.
-
Results
L Jackson, J Cohen, B Sully, S Julious, 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, 2015, 1, 11, doi: 10.1186/s40814-015-0007-1.