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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN37431579
Enrollment
30
Registered
2013-04-09
Start date
2013-05-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 l

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 22, 2026