N/A
N=17
Immuno-nutrition Supplementation in Haemodialysis
Chronic Kidney Disease Requiring Chronic Dialysis
Bottom Line
View on ClinicalTrials.gov: NCT05700851 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: C Reactive Protein - Marker of Systemic Inflammation — 7.3 mg/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Immuno-nutrition supplement (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Nottingham
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY C Reactive Protein - Marker of Systemic Inflammation |
7.3 | — |
| PRIMARY Interleukin-6 - Marker of Systemic Inflammation |
10.5 | — |
| PRIMARY Interleukin-8 - Marker of Systemic Inflammation |
4.9 | — |
| SECONDARY Skeletal Muscle Mass |
26.7 | — |
| SECONDARY Energy Intake |
27.2 | — |
| SECONDARY Protein Intake |
1.1 | — |
| SECONDARY Handgrip Strength - a Measure of Muscle Strength |
24.4 | — |
Summary
The purpose of this pilot study is to test if an "immuno-nutrition" supplement can decrease inflammation in people on haemodialysis. This immuno-nutrition supplement is high in calories and protein like other common nutritional supplements, but also contains a unique combination of ingredients that have been shown to reduce inflammation (a problem which is caused by the body's defence [immune] system communicating that something is wrong) and improve the immune system in people with cancer. The research team hopes that this small study will help with gaining a good understanding of the effect of immuno-nutrition on inflammation in people on haemodialysis, which will guide and allow the research team to do a larger research study in the future.
Eligibility Criteria
Inclusion Criteria
- CRP level >5.0 mg/L.
- At least three haemodialysis sessions per week for ≥3 hours using a biocompatible dialyser.
- Able to give informed consent.
Exclusion Criteria
- Treatment with drugs that cause immunosuppression.
- Non-English speakers or those with special communication needs.
- Pregnancy, breast feeding or intending pregnancy.
- Expected survival 5.0 mmol/L.
- Unable to provide informed consent.
Data sourced from ClinicalTrials.gov (NCT05700851). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.