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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)

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Technical Report,15 Sep 2014,14 Sep 2015

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University of Utah Salt Lake City United States

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This study has not been fully implemented. Clinical trial regulatory processes have taken more time than anticipated in the Statement of Work. An IND from the FDA to use high-dose vitamin D in the NF1 neurofibromatosis type 1population has been obtained, as requested by the University of Utah IRB. The study was approved both by the University of Utah IRB and the DoD USAMRMC ORP HRPO. Ethics board approval from UBC has been approved by HRPO, and U of Cincinnati is under review. The University of Hamburg is working with the European Union Clinical Trials group EurodratCT to implement this study, and a document of agreement to perform a joint clinical trial with the University of Utah has been executed. The Clinical Trials office in Hamburg has reviewed the proposal and we have accommodated the custodianship of study drug, cholecalciferol, from the manufacturer in Canada directly to Germany. Reviews from the IRBs and EurodratCT have led to revision of the manual of operations, which is included in this report. We have instituted monthly conference calls, which has enabled us to finalize the manual of operations to accommodate all 4 sites.

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