Adding nutritional supplements, and protein in particular, to the diet of patients on hemodialysis didn’t seem to bolster their mortality rates, a pragmatic trial found.
In a cluster-randomized clinical trial of over 10,000 patients on hemodialysis, patients on an intensive oral nutritional supplement protocol had similar mortality rates compared with those on standard care (hazard ratio 1.02, 95% CI 0.92-1.14), according to Daniel Weiner, MD, of Tufts Medical Center in Boston.
During the median follow-up of nearly 2 years, 35.8% of patients in the intensive nutrition group died versus 36.5% of patients in the standard nutrition group.
“There’s no difference in mortality outcomes between an intensive and standard oral nutritional supplement protocol,” Weiner stated during a presentation at the American Society of Nephrology virtual Kidney Week.
Overall, protein bars made up half of the nutritional supplements used in the study, followed by LiquaCel, Nepro, Gelatein, Pro-Stat, Body Quest, and Proteinex. Weiner explained that his group aimed for any easily available nutritional supplements with 15 to 20 grams of protein, really emphasizing protein as the overall source of nutrition.
“I think it’s really, really important to say that this doesn’t tell us anything about giving protein supplements to people with low serum albumin,” he pointed out, adding that there’s “reasonable observational data” suggesting that’s still a good practice.
“So this doesn’t speak to people with low serum albumin, it only speaks to people with more normal serum albumin levels,” he said.
Weiner and colleagues conducted the study across 105 Dialysis Clinic facilities. The open-label Health Effects of oral Protein Supplements in HD trial (HELPS-HD) randomized 10,043 hemodialysis patients. Nearly half of the total cohort’s primary cause of kidney failure was diabetes. More than half of the nationally representative cohort were men with a median age of 63, while about 36% were Black.
Those who received the intensive oral nutritional supplement protocol consumed supplements at every dialysis session regardless of serum albumin levels. They were then compared with usual care protocol, which involved patients only receiving oral nutritional supplements during the first 120 days of dialysis and continuing only if albumin was 3.5 g/dL or less, and discontinued oral nutrition if albumin was 4.0 g/dL or higher for 3 months consecutively.
Adherence to oral nutrition was high, as supplement use was two-fold higher among patients at clinics with intensive nutritional protocol.
“We used standard oral nutritional supplements — things that you can buy at any supermarket or store in the United States,” Weiner pointed out, adding that his group tried to keep the trial as pragmatic and “real world” as possible in order to be scalable if the findings were positive. “The most common things that were used were simple protein bars. Things that taste good that people would be happy to eat.”
A study limitation was a lack of data on patient-reported outcomes, such as quality of life.
Weiner said he and his colleagues currently have ongoing analyses in these two groups to further evaluate albumin change, and assess changes within subgroups, such as separating out prevalent versus incident patients.
Kristen Monaco is a staff writer, focusing on endocrinology, psychiatry, and dermatology news. Based out of the New York City office, she’s worked at the company for nearly five years.
The study was funded by Dialysis Clinic.
Weiner disclosed relevant relationships with Tufts Medical Center Physicians Organization, Janssen Biopharmaceuticals, Akebia Cara Therapeutics, Tricida, Dialysis Clinic, Inc., Ardelyx, Cara Therapeutics, AstraZeneca, National Kidney Foundation, and Elsevier. Co-authors disclosed multiple relevant relationships with industry.