A Phase II Trial on the Effect of Low Dose versus High Dose Vitamin D Supplementation on Bone Mass in Adults with Neurofibromatosis 1 (NF1)

Abstract

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 1) population has been obtained, as requested by the University of Utah IRB. There has been one amendment to the original FDA IND approval. 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.

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Document Details

Document Type
Technical Report
Publication Date
Oct 01, 2016
Accession Number
AD1031093

Entities

People

  • David Viskochil

Organizations

  • University of Utah

Tags

Communities of Interest

  • Biomedical

DTIC Thesaurus Topics

  • Acquisition
  • Agreements
  • Biomedical Research
  • British Columbia
  • Clinical Trials
  • Costs
  • Data Acquisition
  • Databases
  • Department Of Defense
  • Electronic Mail
  • European Union
  • Hard Copy
  • Institutional Review Board
  • Neurofibromatosis
  • Storage
  • Universities
  • Vitamin D

Fields of Study

  • Medicine

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  • Clinical Trial Research.