Health Effects of oraL Protein Supplements in HD (The HELPS-HD Trial)

Completed · Not applicable

Conditions studied: End Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT02933151

Run by

Dialysis Clinic, Inc.

People needed

10457

Starts

2017-01-23

Expected to finish

2020-08-31

Last updated by the study team

2024-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Receipt of in-center hemodialysis in a facility participating in the trial
• Able to consume oral nutritional supplements
• Age ≥18 years

You may not qualify if…

• 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

Where it is running

• DCI Jacksonville — Jacksonville, Florida, United States
• Dialysis Clinic, Inc (Corporate) — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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