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

End Stage Renal Disease Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02933151
• Other study ID #: HELPS-HD
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: September 2021

Study information

• Verified date: July 2020
• Source: Dialysis Clinic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10600
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dialysis Clinic, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		end of study - approximately 3 years