Trial reportAnnals of nutrition & metabolism2026
Vitamin Profile of the Patients with Chronic Kidney Disease Receiving a Novel Total Parenteral Nutrition Formula: Multicenter Randomized Controlled Phase III Trial.
Trial report in Annals of nutrition & metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
5 authors.
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Abstract
<p>Introduction: Efficacy and safety of a novel total parenteral nutrition formula for chronic kidney disease patients, OPF-109, containing multivitamins based on the FDA2000 recommendation were investigated.
methodsWe conducted a phase III clinical trial administering OPF-109 (n = 63) or the control solutions (combination of marketed products including multivitamin based on American Medical Association 1975 guidelines) (n = 61) to the chronic kidney disease patients for 8 days. Blood concentrations of proteins and vitamins and safety were evaluated. The primary efficacy endpoint was protein concentration (serum T-P, ALB, pre-ALB, transferrin) on day 8. Safety endpoints were hematological data, blood biochemistry data, vital signs, and adverse events.
resultsValues of blood protein until day 8 were similar in 2 groups although those of vitamins B1, B6, C, and folic acid (contained more in OPF-109) were higher in the OPF-109 group. For both groups, vitamin C concentration of day 1 was below the normal range, which restored to within the range in the OPF-109 group but decreased in the control group on day 8. Vitamin K concentration (contained less in OPF-109) was over the normal range on day 1 in both groups and decreased to slightly higher than the normal range in the OPF-109 group while increased to higher than day 1 value in the control group on day 8. Safety was similar in 2 groups.
conclusionEfficacy and safety of OPF-109 and usefulness of multivitamins based on the FDA2000 recommendation formula were confirmed in chronic kidney disease patients. </p>.
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