Ken Tsuchiya, Tatsukuni Kawakami, Yusuke Maniwa, Yoshiyuki Kawauchi, Motofusa Katayama
{"title":"接受一种新型全肠外营养配方的慢性肾病患者的维生素概况:多中心随机对照III期试验","authors":"Ken Tsuchiya, Tatsukuni Kawakami, Yusuke Maniwa, Yoshiyuki Kawauchi, Motofusa Katayama","doi":"10.1159/000547656","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>Efficacy and safety of OPF-109 and usefulness of multivitamins based on the FDA 2000 recommendations formula were confirmed in chronic kidney disease patients.</p>","PeriodicalId":8269,"journal":{"name":"Annals of Nutrition and Metabolism","volume":" ","pages":"1-27"},"PeriodicalIF":2.9000,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Vitamin Profile of the Patients with Chronic Kidney Disease Receiving a Novel Total Parenteral Nutrition Formula: Multicenter Randomized Controlled Phase III Trial.\",\"authors\":\"Ken Tsuchiya, Tatsukuni Kawakami, Yusuke Maniwa, Yoshiyuki Kawauchi, Motofusa Katayama\",\"doi\":\"10.1159/000547656\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>Efficacy and safety of OPF-109 and usefulness of multivitamins based on the FDA 2000 recommendations formula were confirmed in chronic kidney disease patients.</p>\",\"PeriodicalId\":8269,\"journal\":{\"name\":\"Annals of Nutrition and Metabolism\",\"volume\":\" \",\"pages\":\"1-27\"},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2025-09-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of Nutrition and Metabolism\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1159/000547656\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of Nutrition and Metabolism","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1159/000547656","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
Vitamin Profile of the Patients with Chronic Kidney Disease Receiving a Novel Total Parenteral Nutrition Formula: Multicenter Randomized Controlled Phase III Trial.
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.
期刊介绍:
''Annals of Nutrition and Metabolism'' is a leading international peer-reviewed journal for sharing information on human nutrition, metabolism and related fields, covering the broad and multidisciplinary nature of science in nutrition and metabolism. As the official journal of both the International Union of Nutritional Sciences (IUNS) and the Federation of European Nutrition Societies (FENS), the journal has a high visibility among both researchers and users of research outputs, including policy makers, across Europe and around the world.