CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Vitamin D3 +3 moredrug
Likely dose
Vitamin D3 50,000 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04118010
NCT04118010Phase 4Completed

Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis

Emory University·interventional·Posted Oct 7, 2019·Updated Feb 7, 2024

In Brief

A Phase 4 clinical trial evaluating Vitamin D3, Placebo vitamin D3, and 2 other interventions for Cystic Fibrosis and Dysbiosis. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The study will assess if administration of high-dose vitamin D and a commonly used prebiotic (inulin) is effective to reduce gastrointestinal dysbiosis and to improve critical intestinal functions in Cystic Fibrosis with the additive or synergistic effects of the combination of vitamin D + inulin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedOct 7, 2019
Enrollment StartMar 13, 2020
Primary CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 6.7 years ago

Interventions

Vitamin D3drug

High-dose vitamin D3 50,000 IU /week for 12 weeks

Placebo vitamin D3drug

Matching to Vitamin D3 placebo capsules for 12 weeks

Inulindrug

Chicory-derived prebiotic inulin 12 g/day for 12 weeks

Placebo Inulindrug

Corn-derived maltodextrin 12g/day as the prebiotic placebo for 12 weeks