Status:
COMPLETED
Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis
Lead Sponsor:
Emory University
Conditions:
Cystic Fibrosis
Dysbiosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
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 re...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04118010
Start Date
March 13 2020
End Date
December 31 2022
Last Update
February 7 2024
Active Locations (1)
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1
Emory Clinic
Atlanta, Georgia, United States, 30322