Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis

Emory University

Status and phase: Completed; Phase 4

Conditions: Dysbiosis; Cystic Fibrosis

Treatments: Drug: Placebo Inulin; Drug: Placebo vitamin D3; Drug: Inulin; Drug: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT04118010

IRB00114230

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. male and female patients (age > 18 years) with confirmed CF by genetic mutation and/or sweat chloride testing,
2. not currently on oral or systemic antibiotics for pulmonary exacerbation,
3. vitamin D deficient/insufficient (25(OH)D, 6 - 30 ng/mL) with most recent 25(OH)D in the past 12 months,
4. 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 (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),
5. use of immunosuppressants or history of organ transplantation,
6. current use of probiotics or prebiotics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups, including a placebo group

Vitamin D3 and Inulin

Active Comparator group

Description:

Vitamin D3 50,000 IU/week and 12 g/day chicory-derived prebiotic inulin for 12 weeks

Treatment:

Drug: Vitamin D3

Drug: Inulin

Vitamin D3 and placebo Inulin

Active Comparator group

Description:

Vitamin D3 50,000 IU/week and 12 g/day corn-derived maltodextrin/day as the prebiotic placebo for 12 weeks

Treatment:

Drug: Vitamin D3

Drug: Placebo Inulin

Placebo vitamin D3 and Inulin

Active Comparator group

Description:

Matching to Vitamin D3 placebo capsules, and 12 g/day chicory-derived prebiotic inulin for 12 weeks

Treatment:

Drug: Placebo vitamin D3

Drug: Inulin

Placebo vitamin D3 and placebo Inulin

Placebo Comparator group

Description:

Matching to Vitamin D3 placebo capsules, and 12 g/day corn-derived maltodextrin/day as the prebiotic placebo for 12 weeks

Treatment:

Drug: Placebo vitamin D3

Drug: Placebo Inulin