Intensive Protocol vs Usual Care Protocol: Mortality
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.362 | 0.349 | 0.375 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.369 | 0.355 | 0.382 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00709 | -0.0261 | 0.0119 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.981 | 0.931 | 1.03 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.97 | 0.894 | 1.05 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Intensive Protocol than on Usual Care Protocol | 141 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: usual care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | 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. | 1,856 | 5,133 | OG001 | ClinicalTrials.gov |
| Group 2 | 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. | 1,756 | 4,763 | OG000 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Mortality | ClinicalTrials.gov |
| Description | 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. | ClinicalTrials.gov |
| Time frame | 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. | ClinicalTrials.gov |
| Population | Incident and prevalent hemodialysis patients at 105 participating hemodialysis facilities in the analytic dataset | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Health Effects of oraL Protein Supplements in HD (The HELPS-HD Trial) | ClinicalTrials.gov |
| NCT number | NCT02933151 | ClinicalTrials.gov |
| Phases | NA | ClinicalTrials.gov |
| Conditions | End Stage Renal Disease | ClinicalTrials.gov |
| Interventions | Nutritional Supplement | ClinicalTrials.gov |
| Lead sponsor | Dialysis Clinic, Inc. | ClinicalTrials.gov |
| Results first posted | 2024-11-05 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT02933151?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.