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

NCT02933151 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10457

Last updated 2024-11-05

Study results available
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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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Nutritional Supplement

Selection of which supplement to give to the patients will be left to the dialysis unit's governing body as this study is not interested in a specific supplement's effect on nutrient restoration and subsequent outcomes but rather on oral replacement of amino acids regardless of the agent used.

Sponsors & Collaborators

  • Dialysis Clinic, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Weiner, MD · DCI/Tufts

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-23
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02933151 on ClinicalTrials.gov