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

NCT02933151 | Completed Results

• 1 other identifier: HELPS-HD
• Study Type: interventional
• Target: 10,457
• Locations: 1 country
• Sites: 2

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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Mortality

  All-cause mortality, assessed from day 0 of study initiation in prevalent patients and day 120 of study initiation in incident patients as all incident patients are provided nutritional supplements during their first 120 days of hemodialysis. Withdrawal from dialysis was classified as death. Note that AEs and SAEs were not specifically classified given the minimal risk intervention (protocol prescribing a food containing \~15 g of protein in some participants in usual care facilities and all participants in intensive protocol facilities) and the pragmatic trial design.

  Intervention discontinued on April 13, 2020 due to Covid-related prohibition on eating in facilities. Event follow-up concluded on August 13, 2020. Follow-up time varied among participants, with the maximum of approximately 3.5 years.

Secondary Outcomes (1)

• Hospitalization

  Median 7.1 months (25th to 75th percentile: 3.0, 10.9 months)

Study Arms (2)

Usual Care Protocol

OTHER

Facility randomized to follow the usual care nutritional supplement protocol

Dietary Supplement: Nutritional Supplement

Intensive Protocol

OTHER

Facility randomized to follow the intensive nutritional supplement protocol

Dietary Supplement: Nutritional Supplement

Interventions

Nutritional Supplement DIETARY_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; Usual Care Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Dialysis Clinic, Inc.: lead

Study Sites (2)

DCI Jacksonville

Jacksonville, Florida, 32204, United States

Location

Dialysis Clinic, Inc (Corporate)

Nashville, Tennessee, 37211, United States

Location

Related Publications (1)

• 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.

  PMID: 32390133 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

Cluster-randomized pragmatic clinical trial with baseline clinical data and outcome ascertainment dependent on clinical data entered into the EHR with resultant less rigorous data capture of adverse events than in non-pragmatic trials and therefore a focus on the all-cause mortality outcome. With the COVID pandemic, nutritional supplements were banned during dialysis in all dialysis facilities in April 2020, resulting in cessation of the trial intervention 3 months earlier than planned.

Results Point of Contact

• Title: Dr. Daniel Weiner
• Organization: Dialysis Clinic, Inc. /Tufts Medical Center

dweiner@tuftsmedicalcenter.org

6176365070

Study Officials

• Daniel Weiner, MD

  DCI/Tufts

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 14, 2016
• Study Start: January 23, 2017
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: November 5, 2024
• Results First Posted: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)