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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 and Inulin | Active Comparator | Vitamin D3 50,000 IU/week and 12 g/day chicory-derived prebiotic inulin for 12 weeks |
|
| 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 |
|
| Placebo vitamin D3 and Inulin | Active Comparator | Matching to Vitamin D3 placebo capsules, and 12 g/day chicory-derived prebiotic inulin for 12 weeks |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | High-dose vitamin D3 50,000 IU /week for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in GI Microbiota Diversity | 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. | Baseline, 12 weeks post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vin Tangpricha, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Clinic | Atlanta | Georgia | 30322 | United States |
Individual de-identified participant data (including data dictionaries) be shared with listed investigators
Projected December 2023
Protocol and reported primary and secondary outcomes will be be shared on request for statistical analyses with listed investigators
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D3 and Inulin | Vitamin D3 50,000 IU/week and 12 g/day chicory-derived prebiotic inulin for 12 weeks Vitamin D3: High-dose vitamin D3 50,000 IU /week for 12 weeks Inulin: Chicory-derived prebiotic inulin 12 g/day for 12 weeks |
| FG001 | 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 Vitamin D3: High-dose vitamin D3 50,000 IU /week for 12 weeks Placebo Inulin: Corn-derived maltodextrin 12g/day as the prebiotic placebo for 12 weeks |
| FG002 | Placebo Vitamin D3 and Inulin | Matching to Vitamin D3 placebo capsules, and 12 g/day chicory-derived prebiotic inulin for 12 weeks Placebo vitamin D3: Matching to Vitamin D3 placebo capsules for 12 weeks Inulin: Chicory-derived prebiotic inulin 12 g/day for 12 weeks |
| FG003 | 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 Placebo vitamin D3: Matching to Vitamin D3 placebo capsules for 12 weeks Placebo Inulin: Corn-derived maltodextrin 12g/day as the prebiotic placebo for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients analyzed include participants that completed the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D3 and Inulin | Vitamin D3 50,000 IU/week and 12 g/day chicory-derived prebiotic inulin for 12 weeks Vitamin D3: High-dose vitamin D3 50,000 IU /week for 12 weeks Inulin: Chicory-derived prebiotic inulin 12 g/day for 12 weeks |
| BG001 | Vitamin D3 and Placebo Inulin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Shannon index | Baseline, 12 weeks post-intervention |
|
Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 12.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D3 and Inulin | Vitamin D3 50,000 IU/week and 12 g/day chicory-derived prebiotic inulin for 12 weeks Vitamin D3: High-dose vitamin D3 50,000 IU /week for 12 weeks Inulin: Chicory-derived prebiotic inulin 12 g/day for 12 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vin Tangpricha | Emory University | 404-727-7254 | vtangpr@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2022 | Jan 10, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D064806 | Dysbiosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D007444 | Inulin |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 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 |
|
| Change in GI Microbiota Richness |
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. |
| Baseline, 12 weeks post-intervention |
| Change in GI Microbiota Composition | 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. | Baseline, 12 weeks post-intervention |
Vitamin D3 50,000 IU/week and 12 g/day corn-derived maltodextrin/day as the prebiotic placebo for 12 weeks Vitamin D3: High-dose vitamin D3 50,000 IU /week for 12 weeks Placebo Inulin: Corn-derived maltodextrin 12g/day as the prebiotic placebo for 12 weeks |
| BG002 | Placebo Vitamin D3 and Inulin | Matching to Vitamin D3 placebo capsules, and 12 g/day chicory-derived prebiotic inulin for 12 weeks Placebo vitamin D3: Matching to Vitamin D3 placebo capsules for 12 weeks Inulin: Chicory-derived prebiotic inulin 12 g/day for 12 weeks |
| BG003 | 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 Placebo vitamin D3: Matching to Vitamin D3 placebo capsules for 12 weeks Placebo Inulin: Corn-derived maltodextrin 12g/day as the prebiotic placebo for 12 weeks |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 Vitamin D3: High-dose vitamin D3 50,000 IU /week for 12 weeks Placebo Inulin: Corn-derived maltodextrin 12g/day as the prebiotic placebo for 12 weeks |
| OG002 | Placebo Vitamin D3 and Inulin | Matching to Vitamin D3 placebo capsules, and 12 g/day chicory-derived prebiotic inulin for 12 weeks Placebo vitamin D3: Matching to Vitamin D3 placebo capsules for 12 weeks Inulin: Chicory-derived prebiotic inulin 12 g/day for 12 weeks |
| OG003 | 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 Placebo vitamin D3: Matching to Vitamin D3 placebo capsules for 12 weeks Placebo Inulin: Corn-derived maltodextrin 12g/day as the prebiotic placebo for 12 weeks |
|
|
| Primary | 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. | Stool and serum samples were not collected due to Emory operations being disrupted due to COVID pandemic. | Posted | Baseline, 12 weeks post-intervention |
|
|
| Secondary | Change in GI Microbiota Diversity | 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. | Stool and serum samples were not collected due to Emory operations being disrupted due to COVID pandemic. | Posted | Baseline, 12 weeks post-intervention |
|
|
| Secondary | Change in GI Microbiota Richness | 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. | Stool and serum samples were not collected due to Emory operations being disrupted due to COVID pandemic. | Posted | Baseline, 12 weeks post-intervention |
|
|
| Secondary | Change in GI Microbiota Composition | 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. | Stool and serum samples were not collected due to Emory operations being disrupted due to COVID pandemic. | Posted | Baseline, 12 weeks post-intervention |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | 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 Vitamin D3: High-dose vitamin D3 50,000 IU /week for 12 weeks Placebo Inulin: Corn-derived maltodextrin 12g/day as the prebiotic placebo for 12 weeks | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Placebo Vitamin D3 and Inulin | Matching to Vitamin D3 placebo capsules, and 12 g/day chicory-derived prebiotic inulin for 12 weeks Placebo vitamin D3: Matching to Vitamin D3 placebo capsules for 12 weeks Inulin: Chicory-derived prebiotic inulin 12 g/day for 12 weeks | 0 | 7 | 0 | 7 | 0 | 7 |
| EG003 | 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 Placebo vitamin D3: Matching to Vitamin D3 placebo capsules for 12 weeks Placebo Inulin: Corn-derived maltodextrin 12g/day as the prebiotic placebo for 12 weeks | 0 | 9 | 0 | 9 | 0 | 9 |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |