N/A
Completed N=9,896
Health Effects of oraL Protein Supplements in HD (The HELPS-HD Trial)
Source: ClinicalTrials.gov NCT02933151 ↗Enrolled (actual)
9,896
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Mortality — 1756; 1856 participants
Summary
To conduct a pragmatic randomized clinical trial in which the researchers will determine the mortality impact of a protocol whereby all hemodialysis patients receive an oral, protein-based nutritional supplement during the dialysis procedure as compared to the existing nutritional protocol whereby only hemodialysis patients with serum albumin below 3.5 g/dL and incident hemodialysis patients during the first months of care receive an oral, intradialytic protein-based nutritional supplement during the dialysis procedure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality |
1756; 1856 | — |
| SECONDARY Hospitalization |
3655; 3916 | — |
Eligibility Criteria
Inclusion Criteria
- Receipt of in-center hemodialysis in a facility participating in the trial
- Able to consume oral nutritional supplements
- Age ≥18 years
Exclusion Criteria
- Tube feed or intravenous feed dependent
- Unable to feed oneself or request help with feeding if a supplement is provided
- Known allergy to ingredient(s) of the supplement
Data sourced from ClinicalTrials.gov (NCT02933151). 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. Informational only — not medical advice.