44
Participants
Start Date
June 30, 2011
Primary Completion Date
September 30, 2013
Study Completion Date
September 30, 2013
Vitamin E
A commercial Vitamin E preparation (Aqueous Vitamin E®, 15 IU/0.3 ml; SilaRx, Inc, Spring Valley, NY) will be used for the study, also on the recommendation of the Children's Hospital Colorado (CHC) research pharmacist. The Vitamin E dose will be 18 mg/day for all subjects randomized to the Vitamin E group.
Placebo
The control group will receive an indistinguishable placebo preparation, which will be compounded by the CHC research pharmacy using the following inactive ingredients: purified water, polysorbate 80, sorbital, and propylene glycol. This suspension is stable for 6 months.
University of Colorado Denver, Aurora
University of Colorado, Denver
OTHER