Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. male and female patients (age > 18 years) with confirmed CF by genetic mutation and/or sweat chloride testing,

2. stable pulmonary function (no greater than 5% difference in FEV1% predicted from previous measurement within the past year),

3. not currently on oral or systemic antibiotics for pulmonary exacerbation,

4. vitamin D deficient/insufficient (25(OH)D, 6 - 30 ng/mL) with most recent 25(OH)D in the past 12 months,

5. use of CFTR modulator therapy is allowed

Exclusion Criteria:

1. severe vitamin D deficiency 25(OH)D ≤ 5 ng/mL or hypocalcemia or hypercalcemia,

2. active GI disease, abdominal pain and/or diarrhea,

3. chronic kidney disease worse than stage 3 (eGFR < ml/min per 1.73 m2),

4. any vitamin D supplement use >2,000 IU or vitamin D analogue,

5. use of immunosuppressants or history of organ transplantation,

6. current use of probiotics or prebiotics