Condition category
Urological and Genital Diseases
Date applied
12/03/2013
Date assigned
09/04/2013
Last edited
30/03/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
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
louise.jackson@sth.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Louise Jackson

ORCID ID

Contact details

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

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 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

01/05/2013

Overall trial end date

30/09/2013

Reason abandoned

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

Sponsor information

Organisation

Sheffield Teaching Hospitals NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

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

  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