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

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ClinicalTrials.gov Identifier: NCT02933151
Recruitment Status : Active, not recruiting
First Posted : October 14, 2016
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Dialysis Clinic, Inc.

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Dietary Supplement: Nutritional Supplement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 Start Date : January 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Mortality [ Time Frame: end of study - approximately 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933151


Sponsors and Collaborators
Dialysis Clinic, Inc.
Investigators
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Principal Investigator: Daniel Weiner, MD DCI/Tufts
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dialysis Clinic, Inc.
ClinicalTrials.gov Identifier: NCT02933151    
Other Study ID Numbers: HELPS-HD
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency