Accession Number:

ADA604799

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:

Annual rept. 15 Sep 2012-14 Sep 2013

Corporate Author:

UTAH UNIV SALT LAKE CITY

Personal Author(s):

Report Date:

2013-10-01

Pagination or Media Count:

229.0

Abstract:

This study has received an IND from the FDA to use high-dose vitamin D in the NF1 neurofibromatosis type 1 population. Once the IND was provided by the FDA, the study was approved by the University of Utah IRB. This was reviewed by the DoD USAMRMC ORP HRPO and an amendment was submitted to the University of Utah IRB delineating duties of the Safety Monitor. The amendment was approved, which led to approval by the HRPO. The University of Hamburg has begun the process with the European Union Clinical Trials group EurodratCT, and the group identified a need for a designated legal representative from the sponsoring agency. The DoD has reviewed this request and decided that the University of Utah is the sponsoring agency. After full review from the U of Utah office of sponsored projects OSP, a document of agreement has been drawn up between the University of Utah as the Sponsor and the University Medical Center Hamburg-Eppendorf as the delegated institution. The final draft is under review by both organizations, and once signed, the University of Hamburg can move forward with subcontract review and signature. No funds have been allocated from Utah to the 3 participating centers.

Subject Categories:

  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE