Nutritional outcomes for a randomised investigation of nutritional supplements in patients who receive haemodialysis

ISRCTN	ISRCTN37431579
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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Mrs Louise Jackson
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
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
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

Dietetic Department

Sheffield
S5 7AU
United Kingdom

Sponsor information

Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Anna Leesley
Research and Development Department
11 Broomfield Road
Sheffield
S10 2SE
England
United Kingdom

"ROR"	https://ror.org/018hjpz25

Funders

Funder type

University/education

University of Sheffield (UK) - Student Thesis as part of a Masters in Clinical Research

No information available

Results and Publications

Intention to publish date
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?
Protocol article	protocol	07/10/2013		Yes	No
Results article	results	01/12/2015		Yes	No
HRA research summary			28/06/2023	No	No