The Vitamin D for Enhancing the Immune System in Cystic Fibrosis (DISC) trial: Rationale and design of a multi-center, double-blind, placebo-controlled trial of high dose bolus administration of vitamin D3 during acute pulmonary exacerbation of cystic fibrosis

Contemporary Clinical Trials Communications
Vin TangprichaJessica A Alvarez

Abstract

Vitamin D deficiency is highly prevalent in children and adults with cystic fibrosis (CF). Recent studies have found an association between vitamin D status and risk of pulmonary exacerbations in children and adults with CF. The ongoing Vitamin D for enhancing the Immune System in Cystic fibrosis (DISC) study is a multi-center, double-blind, randomized, placebo-controlled trial that will test the hypothesis of whether high dose vitamin D given as a single oral bolus of 250,000 IU to adults with CF during a pulmonary exacerbation followed by a maintenance dose of vitamin D will improve time to next pulmonary exacerbation and re-hospitalization, improve survival and lung function compared to placebo and reduce the rates of pulmonary exacerbation,. Subjects will be randomized 1:1 at each clinical site to vitamin D or placebo within 72 hours of hospital admission for pulmonary exacerbation. Clinical follow-up visits will occur at 1, 2, 3, and 7 days, and 1, 3, 6 and 12 months after randomization. Blood and sputum will be collected and determination of clinical outcomes will be assessed at each visit. The primary endpoint will be the time to next pulmonary exacerbation requiring antibiotics, re-hospitalization or death. The secondar...Continue Reading

References

Sep 23, 2010·European Journal of Clinical Nutrition·T PincikovaUNKNOWN Scandinavian Cystic Fibrosis Study Consortium
Mar 9, 2012·The Journal of Clinical Endocrinology and Metabolism·V TangprichaUNKNOWN Cystic Fibrosis Foundation Vitamin D Evidence-Based Review Committee
Nov 19, 2014·Nature Reviews. Genetics·Garry R Cutting
Apr 14, 2015·American Journal of Respiratory Cell and Molecular Biology·Rachel E FoongGraeme R Zosky
May 4, 2016·Lancet·J Stuart Elborn

❮ Previous
Next ❯

Citations

Sep 22, 2018·Current Opinion in Endocrinology, Diabetes, and Obesity·Trang N Le
Feb 23, 2019·The American Journal of Clinical Nutrition·Vin TangprichaJessica A Alvarez
Jun 22, 2019·Biometrics·J E Soh, Yijian Huang
Jul 28, 2019·The Cochrane Database of Systematic Reviews·Cristina PalaciosJuan Pablo Peña-Rosas
Oct 4, 2019·The Cochrane Database of Systematic Reviews·Cristina PalaciosJuan Pablo Peña-Rosas
Jul 17, 2020·The Cochrane Database of Systematic Reviews·Matthew N HurleyAlan R Smyth

❮ Previous
Next ❯

Methods Mentioned

BETA
pregnancy test
blood draw
flow cytometry
enzyme-linked immunosorbent assay
ELISA

Clinical Trials Mentioned

NCT01426256

Software Mentioned

SAS
DISC
REDCap
Nutrition Data System for Research
Research Electronic Data Capture ( REDCap )

Related Concepts

Related Feeds

Antifungals (ASM)

An antifungal, also known as an antimycotic medication, is a pharmaceutical fungicide or fungistatic used to treat and prevent mycosis such as athlete's foot, ringworm, candidiasis, cryptococcal meningitis, and others. Discover the latest research on antifungals here.

Antifungals

An antifungal, also known as an antimycotic medication, is a pharmaceutical fungicide or fungistatic used to treat and prevent mycosis such as athlete's foot, ringworm, candidiasis, cryptococcal meningitis, and others. Discover the latest research on antifungals here.