Trial Outcomes & Findings for Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis (NCT NCT04118010)

NCT ID: NCT04118010

Last Updated: 2024-02-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

Baseline, 12 weeks post-intervention

Results posted on

2024-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	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	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	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	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
Overall Study STARTED	10	10	10	10
Overall Study COMPLETED	7	8	7	9
Overall Study NOT COMPLETED	3	2	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin D3 and Inulin n=7 Participants 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	Vitamin D3 and Placebo Inulin n=8 Participants 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	Placebo Vitamin D3 and Inulin n=7 Participants 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	Placebo Vitamin D3 and Placebo Inulin n=9 Participants 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	Total n=31 Participants Total of all reporting groups
Age, Continuous	29.3 years STANDARD_DEVIATION 5.4 • n=5 Participants	29.3 years STANDARD_DEVIATION 7.9 • n=7 Participants	39.6 years STANDARD_DEVIATION 15.6 • n=5 Participants	34.4 years STANDARD_DEVIATION 14.2 • n=4 Participants	33.1 years STANDARD_DEVIATION 11.9 • n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	13 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	18 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	29 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment United States	7 participants n=5 Participants	8 participants n=7 Participants	7 participants n=5 Participants	9 participants n=4 Participants	31 participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vitamin D3 and Inulin n=7 Participants 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	Vitamin D3 and Placebo Inulin n=8 Participants 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	Placebo Vitamin D3 and Inulin n=7 Participants 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	Placebo Vitamin D3 and Placebo Inulin n=9 Participants 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
Shannon Index Baseline	5.02 Shannon index Standard Deviation 0.392	4.96 Shannon index Standard Deviation 0.165	5.28 Shannon index Standard Deviation 0.196	5.73 Shannon index Standard Deviation 0.081
Shannon Index 12 weeks post-intervention	5.02 Shannon index Standard Deviation 0.392	5.05 Shannon index Standard Deviation 0.169	5.24 Shannon index Standard Deviation 0.229	5.41 Shannon index Standard Deviation 0.097

PRIMARY outcome

Timeframe: Baseline, 12 weeks post-intervention

Population: Stool and serum samples were not collected due to Emory operations being disrupted due to COVID pandemic.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 weeks post-intervention

Population: Stool and serum samples were not collected due to Emory operations being disrupted due to COVID pandemic.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 weeks post-intervention

Population: Stool and serum samples were not collected due to Emory operations being disrupted due to COVID pandemic.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 weeks post-intervention

Population: Stool and serum samples were not collected due to Emory operations being disrupted due to COVID pandemic.

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.

Outcome measures

Outcome data not reported

Adverse Events

Vitamin D3 and Inulin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vitamin D3 and Placebo Inulin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Vitamin D3 and Inulin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Vitamin D3 and Placebo Inulin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Vin Tangpricha

Emory University

Phone: 404-727-7254

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place