NCT04118010

Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Cystic fibrosis (CF) is the most common life-shortening genetic condition among Caucasians in the United States. Individuals with CF have an altered gastrointestinal (GI) microbiota, which may be a result of chronic systemic inflammation and infection, frequent use of antibiotics, and/or medically prescribed and habitual high-fat/high-calorie diets. 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.

Conditions

• Cystic Fibrosis
• Dysbiosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-03-13
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2019-10-07
• Last updated: 2024-02-07
• Results posted: 2024-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study