Trial Outcomes & Findings for Health Effects of oraL Protein Supplements in HD (The HELPS-HD Trial) (NCT NCT02933151)

Last Updated: 2024-11-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

10457 participants

Primary outcome timeframe

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.

Results posted on

2024-11-05

Participant Flow

There were 10457 patients consented in participating facilities. Because all incident patients, regardless of facility allocation, received an identical nutritional supplement protocol for the first 120 days, incident patients are excluded from analyses for the 1st 120 days. This results in an analytic dataset of 9896 individuals that serves as the basis for Table 1 and all primary analyses.

Unit of analysis: Hemodialysis Facilities

Participant milestones

Participant milestones
Measure	Usual Care Protocol Facility randomized to follow the usual care nutritional supplement protocol 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 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.
Overall Study STARTED	4763 52	5133 53
Overall Study COMPLETED	2215 52	2320 53
Overall Study NOT COMPLETED	2548 0	2813 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care Protocol Facility randomized to follow the usual care nutritional supplement protocol 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 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.
Overall Study Lost to Follow-up	19	18
Overall Study Death	1732	1827
Overall Study Transplant	210	278
Overall Study Withdrawal from HD (Death equivalent analytically)	24	29
Overall Study Transferred to PD or a non-DCI facility	516	632
Overall Study Recovered Kidney Function	47	29

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care Protocol n=4763 Participants Facility randomized to follow the usual care nutritional supplement protocol 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 n=5133 Participants Facility randomized to follow the intensive nutritional supplement protocol 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.	Total n=9896 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2357 Participants n=5 Participants	2591 Participants n=7 Participants	4948 Participants n=5 Participants
Age, Categorical >=65 years	2406 Participants n=5 Participants	2542 Participants n=7 Participants	4948 Participants n=5 Participants
Age, Continuous	63.4 years STANDARD_DEVIATION 14.2 • n=5 Participants	62.6 years STANDARD_DEVIATION 14.8 • n=7 Participants	63.0 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	2081 Participants n=5 Participants	2248 Participants n=7 Participants	4329 Participants n=5 Participants
Sex: Female, Male Male	2682 Participants n=5 Participants	2885 Participants n=7 Participants	5567 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	183 Participants n=5 Participants	379 Participants n=7 Participants	562 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1648 Participants n=5 Participants	1930 Participants n=7 Participants	3578 Participants n=5 Participants
Race (NIH/OMB) White	2631 Participants n=5 Participants	2365 Participants n=7 Participants	4996 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	301 Participants n=5 Participants	459 Participants n=7 Participants	760 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Population: Incident and prevalent hemodialysis patients at 105 participating hemodialysis facilities in the analytic dataset

Outcome measures

Outcome measures
Measure	Usual Care Protocol n=52 Hemodialysis Facilities Facility randomized to follow the usual care nutritional supplement protocol 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 n=53 Hemodialysis Facilities Facility randomized to follow the intensive nutritional supplement protocol 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.
Mortality	1756 participants	1856 participants

SECONDARY outcome

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

Population: First hospitalization in the lagged analyses

Time to First Hospitalization

Outcome measures

Outcome measures
Measure	Usual Care Protocol n=52 Hemodialysis Facilities Facility randomized to follow the usual care nutritional supplement protocol 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 n=53 Hemodialysis Facilities Facility randomized to follow the intensive nutritional supplement protocol 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.
Hospitalization	3655 Patient level hospitalizations	3916 Patient level hospitalizations

Adverse Events

Usual Care Protocol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1732 deaths

Intensive Protocol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1827 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Weiner

Dialysis Clinic, Inc. /Tufts Medical Center

Phone: 6176365070

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place