Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2024
• Main ID: NCT04118010
• Date of registration: 04/10/2019
• Prospective Registration: Yes
• Primary sponsor: Emory University
• Public title: Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis
• Scientific title: Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis
• Date of first enrolment: March 13, 2020
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04118010
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Vin Tangpricha, MD
• Affiliation: Emory University

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Dysbiosis

Cystic Fibrosis

Intervention(s)

Drug: Inulin

Drug: Placebo vitamin D3

Drug: Placebo Inulin

Drug: Vitamin D3

Primary Outcome(s)

Change in Shannon Index from baseline [Time Frame: Baseline, 12 weeks post-intervention]

Change in Species Richness Index from baseline [Time Frame: Baseline, 12 weeks post-intervention]

Secondary Outcome(s)

Change in GI microbiota composition [Time Frame: Baseline, 12 weeks post-intervention]

Change in GI microbiota richness [Time Frame: Baseline, 12 weeks post-intervention]

Change in GI microbiota diversity [Time Frame: Baseline, 12 weeks post-intervention]

Secondary ID(s)

IRB00114230

Source(s) of Monetary Support

Please refer to primary and secondary sponsors