Vitamin D Supplementation for Adults With Neurofibromatosis Type 1 (NF1)

Summary

This clinical trial is conducted by one of 4 locations; University of British Columbia (Vancouver, CA), University of Utah (Salt Lake City, UT, USA), University of Cincinnati (Cincinnati, OH, USA), and University of Hamburg (Hamburg, Germany).

Adults with NF1 have a higher risk of osteopenia and osteoporosis, a condition of low bone density that can lead to fragile bones and bone breakage.

People with NF1 also have lower vitamin D levels than unaffected individuals. Vitamin D is important for normal bone health, but studies to improve bone health by vitamin D supplementation in people with NF1 have not been tried.

The purpose of this study is to treat adults with NF1 who have insufficient serum vitamin D levels with 2 different doses of vitamin D supplementation to determine if vitamin D supplementation ameliorates the usual loss of bone mineral density over 2 years.

Conditions

• Neurofibromatosis Type 1 (NF1)

Interventions

DRUG

Cholecalciferol

DDrops(trademark) prepared two sets of bottles, one set has 300IU per metered dose and the other set has 2,000IU per metered dose. Participants are randomized to either 600 IU or 4,000 IU, and they take two measured drops orally, once a day. There is a dropper that automatically drops out a measured amount when the bottle is turned upside down.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command

  collaborator FED

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• University of Utah

  lead OTHER

Principal Investigators

• David H. Viskochil, MD, PhD · University of Utah

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

25 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-16

Primary Completion

2022-01-01

Completion

2022-01-01

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations