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

January 20, 2021 updated by: Dialysis Clinic, Inc.

Health Effects of oraL Protein Supplements in HD (The HELPS-HD Trial) An Open-Label Cluster Randomized Pragmatic Trial Evaluating the Effectiveness of Oral Intradialytic Nutritional Supplements on Mortality in Hemodialysis Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10600

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Tube feed or intravenous feed dependent
  2. Unable to feed oneself or request help with feeding if a supplement is provided
  3. Known allergy to ingredient(s) of the supplement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Usual Care Protocol
Facility randomized to follow the usual care nutritional supplement protocol
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.
Other: Intensive Protocol
Facility randomized to follow the intensive nutritional supplement protocol
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: end of study - approximately 3 years
end of study - approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dialysis Clinic, Inc.

Investigators

  • Principal Investigator: Daniel Weiner, MD, DCI/Tufts

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

October 12, 2016

First Submitted That Met QC Criteria

October 13, 2016

First Posted (Estimate)

October 14, 2016

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HELPS-HD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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