Accession Number:

AD1048508

Title:

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)

Descriptive Note:

Technical Report,15 Sep 2016,14 Sep 2017

Corporate Author:

University of Utah Salt Lake City United States

Personal Author(s):

Report Date:

2017-10-01

Pagination or Media Count:

13.0

Abstract:

This study is now ready to be fully implemented at 3 of 4 sites. Vitamin D has been randomized and the database is built. Participants are being recruited by 3 of the 4 sites.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. The study was approved both by the University of Utah IRB and the DoD USAMRMCORP HRPO. Ethics board approval from UBC has been approved by HRPO, and U of Cincinnati is IRB and HRPO approved. 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.

Subject Categories:

  • Medicine and Medical Research
  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE