Vitamin Profile of the Patients with Chronic Kidney Disease Receiving a Novel Total Parenteral Nutrition Formula: Multicenter Randomized Controlled Phase III Trial.

Abstract

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.

Methods: We 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 Day8. Safety endpoints were hematological data, blood biochemistry data, vital signs, and adverse events.

Results: Values of blood protein until Day8 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 Day1 was below the normal range, which restored to within the range in the OPF-109 group but decreased in the control group on Day8. Vitamin K concentration (contained less in OPF-109) was over the normal range on Day1 in both groups and decreased to slightly higher than the normal range in the OPF-109 group while increased to higher than Day1 value in the control group on Day8. Safety was similar in 2 groups.

Conclusion: Efficacy and safety of OPF-109 and usefulness of multivitamins based on the FDA 2000 recommendations formula were confirmed in chronic kidney disease patients.