A Phase 2 Trial on the Effect of Low-Dose versus High-Dose Vitamin D Supplementation on Bone Mass in Adults with Neurofibromatosis 1 (NF1)
Annual rept. 15 Sep 2013-14 Sep 2014
UTAH UNIV SALT LAKE CITY
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This study has not been fully implemented. As a clinical trial the regulatory processes have taken more time than anticipated in the Statement of Work. This study has received an IND from the FDA to use high-dose vitamin D in the NF1 neurofibromatosis type 1 population. The study was approved both by the University of Utah IRB and the DoD USAMRMC ORP HRPO in February, 2014. The University of Hamburg is working with the European Union Clinical Trials group EurodratCT to implement this study. A document of agreement has been executed between the University of Utah as the Legal Representative, or Sponsor, and the University Medical Center Hamburg-Eppendorf as the Delegated Institution. The Clinical Trials office in Hamburg is assessing the manufacture, shipment, and custodianship of study drug, cholecalciferol, from the manufacturer in Canada to the medical monitor at the U of Utah for relabeling, and final shipping to Germany. The U of Cincinnati has IRB approval, which will be reviewed by the U of Utah IRB prior to submission to the DoD HRPO for review. UBC has submitted final protocol revisions to its ethics committee. No funds have been allocated from Utah to the 3 participating centers.
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