{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T18:00:50Z","timestamp":1771264850199,"version":"3.50.1"},"reference-count":14,"publisher":"S. Karger AG","issue":"1","license":[{"start":{"date-parts":[[2025,9,4]],"date-time":"2025-09-04T00:00:00Z","timestamp":1756944000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,9,4]],"date-time":"2025-09-04T00:00:00Z","timestamp":1756944000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Ann Nutr Metab"],"abstract":"<jats:p>&lt;p&gt;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 day 8. Safety endpoints were hematological data, blood biochemistry data, vital signs, and adverse events. Results: Values 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. Conclusion: Efficacy and safety of OPF-109 and usefulness of multivitamins based on the FDA2000 recommendation formula were confirmed in chronic kidney disease patients. &lt;\/p&gt;<\/jats:p>","DOI":"10.1159\/000547656","type":"journal-article","created":{"date-parts":[[2025,9,4]],"date-time":"2025-09-04T16:00:56Z","timestamp":1757001656000},"page":"36-50","source":"Crossref","is-referenced-by-count":0,"title":["Vitamin Profile of the Patients with Chronic Kidney Disease Receiving a Novel Total Parenteral Nutrition Formula: Multicenter Randomized Controlled Phase III Trial"],"prefix":"10.1159","volume":"82","author":[{"given":"Ken","family":"Tsuchiya","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tatsukuni","family":"Kawakami","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yusuke","family":"Maniwa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0852-5947","authenticated-orcid":false,"given":"Yoshiyuki","family":"Kawauchi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Motofusa","family":"Katayama","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"127","published-online":{"date-parts":[[2025,9,4]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2020.05.006"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1016\/j.clnu.2021.01.028"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1159\/000524625"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1159\/000497227"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1214\/aoms\/1177731287"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1016\/j.clnu.2022.02.015"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1016\/j.kint.2016.03.010"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1111\/sdi.12099"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1016\/j.ekir.2020.09.009"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1159\/000183353"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.3390\/nu9030282"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/17.3.422"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1111\/hdi.12705"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.1046\/j.1523-1755.1999.00479.x"}],"container-title":["Annals of Nutrition and Metabolism"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/karger.com\/article-pdf\/doi\/10.1159\/000547656","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T17:00:52Z","timestamp":1771261252000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000547656"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,4]]},"references-count":14,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,2,16]]},"published-print":{"date-parts":[[2026,2,18]]}},"URL":"https:\/\/doi.org\/10.1159\/000547656","archive":["Portico"],"relation":{"is-supplemented-by":[{"id-type":"doi","id":"10.6084\/m9.figshare.30041140","asserted-by":"subject"}]},"ISSN":["0250-6807","1421-9697"],"issn-type":[{"value":"0250-6807","type":"print"},{"value":"1421-9697","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,4]]}}}