Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis

NCT04118010 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00114230
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 Cystic Fibrosis with the additive or synergistic effects of the combination of vitamin D + inulin.

Conditions

Cystic Fibrosis; Dysbiosis

Keywords

Cystic Fibrosis; Gastrointestinal Dysbiosis; Vitamin D; Prebiotic; Inulin; Gut microbiome; Intestinal inflammation; Intestinal absorption

Outcome Measures

Primary Outcomes (2)

• Shannon Index

  The Shannon Index is a measure of diversity of microbial species that takes into account both abundance (the number of species present) and evenness (how close the numbers for each species are). The Shannon index can be calculated using the following equation: H= -∑(i=1)\^s pi ln(pi). A value of zero for H indicates that a community has only one species. The higher the value of H, the higher the diversity of species in a particular community. Sputum microbiota analysis was measured using this ecological diversity measure. Sputum samples were collected via a sputum kit.

  Baseline, 12 weeks post-intervention

• Change in Species Richness Index From Baseline

  Stool microbiota analysis will be measured using this ecological diversity measure. Stool samples will be collected using a stool kit provided to the participant.

  Baseline, 12 weeks post-intervention

Secondary Outcomes (3)

• Change in GI Microbiota Diversity

  Baseline, 12 weeks post-intervention

• Change in GI Microbiota Richness

  Baseline, 12 weeks post-intervention

• Change in GI Microbiota Composition

  Baseline, 12 weeks post-intervention

Study Arms (4)

Vitamin D3 and Inulin

ACTIVE COMPARATOR

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

Drug: Vitamin D3; Drug: Inulin

Vitamin D3 and placebo Inulin

ACTIVE COMPARATOR

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

Drug: Vitamin D3; Drug: Placebo Inulin

Placebo vitamin D3 and Inulin

ACTIVE COMPARATOR

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

Drug: Placebo vitamin D3; Drug: Inulin

Placebo vitamin D3 and placebo Inulin

PLACEBO COMPARATOR

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

Drug: Placebo vitamin D3; Drug: Placebo Inulin

Interventions

Vitamin D3 DRUG

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

Vitamin D3 and Inulin; Vitamin D3 and placebo Inulin

Placebo vitamin D3 DRUG

Matching to Vitamin D3 placebo capsules for 12 weeks

Placebo vitamin D3 and Inulin; Placebo vitamin D3 and placebo Inulin

Inulin DRUG

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

Placebo vitamin D3 and Inulin; Vitamin D3 and Inulin

Placebo Inulin DRUG

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

Placebo vitamin D3 and placebo Inulin; Vitamin D3 and placebo Inulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Dysbiosis

Interventions

Cholecalciferol; Inulin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Results Point of Contact

• Title: Dr. Vin Tangpricha
• Organization: Emory University

vtangpr@emory.edu

404-727-7254

Study Officials

• Vin Tangpricha, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 7, 2019
• Study Start: March 13, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 7, 2024
• Results First Posted: February 7, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Projected December 2023
• Access Criteria: Protocol and reported primary and secondary outcomes will be be shared on request for statistical analyses with listed investigators

Locations

US (1)