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

Primary Purpose

End Stage Renal Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutritional Supplement
Sponsored by
Dialysis Clinic, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for End Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Usual Care Protocol

    Intensive Protocol

    Arm Description

    Facility randomized to follow the usual care nutritional supplement protocol

    Facility randomized to follow the intensive nutritional supplement protocol

    Outcomes

    Primary Outcome Measures

    Mortality

    Secondary Outcome Measures

    Full Information

    First Posted
    October 12, 2016
    Last Updated
    January 20, 2021
    Sponsor
    Dialysis Clinic, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02933151
    Brief Title
    Health Effects of oraL Protein Supplements in HD (The HELPS-HD Trial)
    Acronym
    HELPS-HD
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    September 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Dialysis Clinic, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    End Stage Renal Disease

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10600 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual Care Protocol
    Arm Type
    Other
    Arm Description
    Facility randomized to follow the usual care nutritional supplement protocol
    Arm Title
    Intensive Protocol
    Arm Type
    Other
    Arm Description
    Facility randomized to follow the intensive nutritional supplement protocol
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Nutritional Supplement
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Mortality
    Time Frame
    end of study - approximately 3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel Weiner, MD
    Organizational Affiliation
    DCI/Tufts
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32390133
    Citation
    Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.
    Results Reference
    derived

    Learn more about this trial

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

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