Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-13

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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

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Cystic Fibrosis Dysbiosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vitamin D3 and Inulin

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

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DRUG

High-dose vitamin D3 50,000 IU /week for 12 weeks

Inulin

Intervention Type DRUG

Chicory-derived prebiotic inulin 12 g/day for 12 weeks

Vitamin D3 and placebo Inulin

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

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DRUG

High-dose vitamin D3 50,000 IU /week for 12 weeks

Placebo Inulin

Intervention Type DRUG

Corn-derived maltodextrin 12g/day as the prebiotic placebo for 12 weeks

Placebo vitamin D3 and Inulin

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

Group Type ACTIVE_COMPARATOR

Placebo vitamin D3

Intervention Type DRUG

Matching to Vitamin D3 placebo capsules for 12 weeks

Inulin

Intervention Type DRUG

Chicory-derived prebiotic inulin 12 g/day for 12 weeks

Placebo vitamin D3 and placebo Inulin

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

Group Type PLACEBO_COMPARATOR

Placebo vitamin D3

Intervention Type DRUG

Matching to Vitamin D3 placebo capsules for 12 weeks

Placebo Inulin

Intervention Type DRUG

Corn-derived maltodextrin 12g/day as the prebiotic placebo for 12 weeks

Interventions

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Vitamin D3

High-dose vitamin D3 50,000 IU /week for 12 weeks

Intervention Type DRUG

Placebo vitamin D3

Matching to Vitamin D3 placebo capsules for 12 weeks

Intervention Type DRUG

Inulin

Chicory-derived prebiotic inulin 12 g/day for 12 weeks

Intervention Type DRUG

Placebo Inulin

Corn-derived maltodextrin 12g/day as the prebiotic placebo for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No