Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Haemodialysis is a form of renal replacement therapy that clears the blood of toxins when a person’s 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

Trial website

Contact information



Primary contact

Mrs Louise Jackson


Contact details

Dietetic Department
Old Nurses Home
Northern General Hospital
Herries Road
S5 7AU
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Nutritional OUtcomes from a Randomised Investigation of intradialytic oral nutritional Supplements in patients receiving Haemodialysis



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


Secondary study design

Randomised controlled trial

Trial setting


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


Haemodialysis - a form of renal replacement therapy


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



Not Applicable

Drug names

Nutritional supplements

Primary outcome measures

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


Overall trial end date


Reason abandoned


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Dietetic Department
S5 7AU
United Kingdom

Sponsor information


Sheffield Teaching Hospitals NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre



Funder type


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


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

Results - basic reporting

Publication summary

2013 protocol in:
2015 results in:

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes