d6-25-hydroxyvitamin D3 for Cystic Fibrosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cystic Fibrosis+1 More
d6-25-hydroxyvitamin D3 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is looking at how well vitamin D is metabolized in people with CF compared to people without CF.

Eligible Conditions
  • Cystic Fibrosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 8 weeks

7 days
serum concentration of ALT
serum concentration of AST
serum concentration of calcium
serum concentration of creatinine
8 weeks
AUC of D6-25(OH)D3
Metabolic clearance of D6-25(OH)D3
Metabolic formation clearance of D6-25(OH)D3 metabolites
Terminal half-life of D6-25(OH)D3
Volume of distribution of D6-25(OH)D3

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Single pharmacokinetics arm
1 of 1
Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: d6-25-hydroxyvitamin D3 · No Placebo Group · Phase 1

Single pharmacokinetics arm
Drug
Experimental Group · 1 Intervention: d6-25-hydroxyvitamin D3 · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,583 Previous Clinical Trials
1,565,976 Total Patients Enrolled
20 Trials studying Cystic Fibrosis
44,755 Patients Enrolled for Cystic Fibrosis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,122 Previous Clinical Trials
5,054,034 Total Patients Enrolled
24 Trials studying Cystic Fibrosis
14,321 Patients Enrolled for Cystic Fibrosis
Ian de Boer, MD, MSPrincipal InvestigatorUniversity of Washington
2 Previous Clinical Trials
107 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Serum total 25(OH)D is below 50 ng/mL.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: October 20th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.