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Completed

NCT Number: NCT04118010

Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory Clinic

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Vitamin D3

Drug

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

Placebo vitamin D3

Drug

Matching to Vitamin D3 placebo capsules for 12 weeks

inulin

Drug

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

Placebo Inulin

Drug

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

Primary outcomes

  1. Shannon Index

    Time frame: Baseline, 12 weeks post-intervention

    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.

  2. Change in Species Richness Index From Baseline

    Time frame: Baseline, 12 weeks post-intervention

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

Secondary outcomes

  1. Change in GI Microbiota Diversity

    Time frame: Baseline, 12 weeks post-intervention

    Changes in GI microbiota diversity will be determined using 16S rRNA gene sequencing and microbiome-dependent metabolites pathways in stool and plasma using high-resolution metabolomics analysis.Changes in GI microbiota diversity will be reported as the Shannon Index.

  2. Change in GI Microbiota Richness

    Time frame: Baseline, 12 weeks post-intervention

    Changes in GI microbiota richness will be determined using 16S rRNA gene sequencing and microbiome-dependent metabolites pathways in stool and plasma using high-resolution metabolomics analysis.Changes in GI microbiota richness will be reported as a number of populations of microorganisms.

  3. Change in GI Microbiota Composition

    Time frame: Baseline, 12 weeks post-intervention

    Changes in GI microbiota composition will be determined using 16S rRNA gene sequencing and microbiome-dependent metabolites pathways in stool and plasma using high-resolution metabolomics analysis.Changes in GI microbiota composition will be reported as a percentage of bacteria.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 7, 2019
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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