Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis

Completed · Phase 4 · Has a placebo group

Conditions studied: Cystic Fibrosis, Dysbiosis

In brief

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.

Key facts

Study ID

NCT04118010

Run by

Emory University

People needed

40

Starts

2020-03-13

Expected to finish

2022-12-31

Last updated by the study team

2024-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 < ml/min per 1.73 m2),
• any vitamin D supplement use >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

Where it is running

• Emory Clinic — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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