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Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis

NCT04118010 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-02-07

Study results available
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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.

Conditions

Interventions

DRUG

Vitamin D3

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

DRUG

Placebo vitamin D3

Matching to Vitamin D3 placebo capsules for 12 weeks

DRUG

Inulin

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

DRUG

Placebo Inulin

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

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Vin Tangpricha, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-13
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04118010 on ClinicalTrials.gov