{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T01:23:56Z","timestamp":1784165036277,"version":"3.55.0"},"reference-count":54,"publisher":"S. Karger AG","issue":"6","license":[{"start":{"date-parts":[[2014,1,1]],"date-time":"2014-01-01T00:00:00Z","timestamp":1388534400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.karger.com\/Services\/SiteLicenses"},{"start":{"date-parts":[[2014,1,1]],"date-time":"2014-01-01T00:00:00Z","timestamp":1388534400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.karger.com\/Services\/SiteLicenses"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Am J Nephrol"],"published-print":{"date-parts":[[2014]]},"abstract":"<jats:p>&lt;b&gt;&lt;i&gt;Background\/Aims:&lt;\/i&gt;&lt;\/b&gt; Vitamin D insufficiency drives secondary hyperparathyroidism (SHPT) and is associated with increased cardiovascular mortality in patients with chronic kidney disease (CKD). SHPT is poorly addressed by current vitamin D repletion options. The present study evaluated a novel investigational vitamin D repletion therapy: a modified-release (MR) formulation of calcifediol designed to raise serum 25-hydroxyvitamin D in a gradual manner to minimize the induction of CYP24 and, thereby, improve the SHPT control. &lt;b&gt;&lt;i&gt;Methods:&lt;\/i&gt;&lt;\/b&gt; This randomized, double-blind, placebo-controlled trial evaluated MR calcifediol in CKD subjects (n = 78) with plasma intact parathyroid hormone (iPTH) &gt;70 pg\/ml and serum total 25-hydroxyvitamin D &lt;30 ng\/ml. Subjects received daily treatment for six weeks with oral MR calcifediol (30, 60 or 90 \u00b5g) or a placebo. &lt;b&gt;&lt;i&gt;Results:&lt;\/i&gt;&lt;\/b&gt; More than 90% of subjects treated with MR calcifediol achieved serum 25-hydroxyvitamin D levels \u226530 ng\/ml versus 3% of subjects treated with placebo (p &lt; 0.0001). Mean plasma iPTH decreased from baseline (140.3 pg\/ml) by 20.9 \u00b1 6.2% (SE), 32.8 \u00b1 5.7 and 39.3 \u00b1 4.3% in the 30, 60 and 90 \u00b5g dose groups, respectively, and increased 17.2 \u00b1 7.8% in the pooled placebo group (p &lt; 0.005). No clinically significant safety concerns arose during MR calcifediol treatment. &lt;b&gt;&lt;i&gt;Conclusion:&lt;\/i&gt;&lt;\/b&gt; Oral MR calcifediol appears safe and highly effective in treating SHPT associated with vitamin D insufficiency in CKD.<\/jats:p>","DOI":"10.1159\/000369939","type":"journal-article","created":{"date-parts":[[2015,1,7]],"date-time":"2015-01-07T10:02:17Z","timestamp":1420624937000},"page":"535-545","source":"Crossref","is-referenced-by-count":55,"title":["Modified-Release Calcifediol Effectively Controls Secondary Hyperparathyroidism Associated with Vitamin D Insufficiency in Chronic Kidney Disease"],"prefix":"10.1159","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3330-0179","authenticated-orcid":false,"given":"Stuart M.","family":"Sprague","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arnold 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