Effect and Safety of Viusid ® on Quality of Life in Patients with Chronic Kidney Disease Undergoing Haemodialysis

Abstract

Introduction: The primary goal in the treatment of patients with Chronic Kidney Disease (CKD) undergoing dialysis is to optimise parameters that support an improved Quality of Life (QoL). Nutritional supplements have been widely used for this purpose. Objective: To evaluate the effect and safety of the nutritional supplement Viusid ® in a cohort of patients with stage 5 CKD undergoing haemodialysis. Material and methods: This was an open-label, multicentre, prospective, uncontrolled study. Sixty patients from the Dr. Abelardo Bush López Institute of Nephrology and the Hermanos Ameijeiras Surgical Clinical Hospital in Havana, Cuba, were included. Patients received one vial of Viu sid ® daily for six months and were evaluated at three time points. Clinical and sociodemographic data were collected from each patient. The primary outcome was quality of life, assessed using the SF-36 QoL questionnaire. Secondary outcomes included the presence and severity of symptoms and signs, anthropometric measurements, haematological, biochemical and immunological profiles, and safety. Results: The mean age was 49.27 ± 1.64 years, with a predominance of male patients. Hypertension was the leading cause of kidney damage (33.3%). The sample size decreased from 60 to 43 patients who completed all evaluations. Significant absolute increases were observed in each of the eight SF-36 QoL dimensions, exceeding the non-inferiority margin ( δ = −5), indicating that scores either remained stable or improved from baseline (month 0) to month 6. Improvements were observed in symptoms such as cramps, pain, and sleep disturbances, along with stabilisation in nutritional categories. Haemoglobin and haematocrit levels remained outside normal ranges, with no additional deviations attributable to treatment. Albumin, total protein, transferrin, and C-Reactive Protein (CRP) levels showed improvement. The proportion of adverse events was 33% related to haemodialysis and 20% related to Viusid ® . Conclusions: Improvement or maintenance of SF-36 QoL scores was achieved, particularly in the domains of general health, physical functioning, social functioning, and bodily pain. Viusid ® was found to be safe, with a low incidence of adverse events.