ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	13 January 2015
Main ID:	ISRCTN37431579
Date of registration:	09/04/2013
Prospective Registration:	Yes
Primary sponsor:	Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Public title:	Nutritional outcomes for a randomised investigation of nutritional supplements in patients who receive haemodialysis
Scientific title:	Nutritional OUtcomes from a Randomised Investigation of intradialytic oral nutritional Supplements in patients receiving Haemodialysis
Date of first enrolment:	01/05/2013
Target sample size:	30
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN37431579
Study type:	Interventional
Study design:	Single centre two-arm parallel group randomised controlled pilot trial (Quality of life)
Phase:

Countries of recruitment
United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Louise Jackson
Address:	Dietetic Department Old Nurses Home Northern General Hospital Herries Road S5 7AU Sheffield United Kingdom
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Haemodialysis - a form of renal replacement therapy
Urological and Genital Diseases

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

001

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.