Phase 4 N=40 Randomized Double-blind Treatment

Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis

Cystic Fibrosis · Dysbiosis

Bottom Line

View on ClinicalTrials.gov: NCT04118010 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2024

Primary outcome: Primary: Shannon Index — 5.02; 4.96; 5.28; 5.73 Shannon index

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Vitamin D3 (Drug); Placebo vitamin D3 (Drug); Inulin (Drug); Placebo Inulin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Shannon Index	5.02; 4.96; 5.28; 5.73; 5.02; 5.05	—
PRIMARY Change in Species Richness Index From Baseline	—	—
SECONDARY Change in GI Microbiota Diversity	—	—
SECONDARY Change in GI Microbiota Richness	—	—
SECONDARY Change in GI Microbiota Composition	—	—

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.

Eligibility Criteria

Inclusion Criteria

male and female patients (age > 18 years) with confirmed CF by genetic mutation and/or sweat chloride testing,
not currently on oral or systemic antibiotics for pulmonary exacerbation,
vitamin D deficient/insufficient (25(OH)D, 6 - 30 ng/mL) with most recent 25(OH)D in the past 12 months,
use of CFTR modulator therapy is allowed

Exclusion Criteria

severe vitamin D deficiency 25(OH)D ≤ 5 ng/mL or hypocalcemia or hypercalcemia,
active GI disease, abdominal pain and/or diarrhea,
chronic kidney disease worse than stage 3 (eGFR 2,000 IU or vitamin D analogue (patients who are taking more than 2,000 IU of vitamin D must agree to stop the vitamin D for 6 weeks and take less than 2,000 IU of vitamin D during the study),
use of immunosuppressants or history of organ transplantation,
current use of probiotics or prebiotics

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04118010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.