Back to resultsVitamin D and Microbiota in Cystic Fibrosis
Primary Purpose
Vitamin D Deficiency, Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-Dose Vitamin D3
Stool Sample
Sputum Sample
Sham Comparator
Blood draw
Sponsored by
About this trial
This is an interventional supportive care trial for Vitamin D Deficiency focused on measuring Clinical Endocrinology, Immunology, Inflammation, Microbiology, Respiratory Disorders, Vitamins
Eligibility Criteria
Inclusion Criteria:
- Presenting to the Cystic fibrosis clinic for routine follow up of cystic fibrosis
- Serum 25(OH)D concentrations obtained within 2 months of enrollment
- Able to tolerate oral medications
Exclusion Criteria:
- Inability to obtain or declined informed consent from the subject and/or legally authorized representative
- Pregnancy or plans to become pregnant in the next 3 months
- History of disorders associated with hypercalcemia including parathyroid disease
- Current hypercalcemia (albumin-corrected serum calcium >10.8 mg/dL or ionized calcium >5.2 mg/dL)
- History of nephrolithiasis with active symptoms within the past two years
- Chronic kidney disease worse than stage III (<60 ml/min)
- Current significant hepatic dysfunction total bilirubin > 2.5 mg/dL with direct bilirubin > 1.0 mg/dL
- Current use of cytotoxic or immunosuppressive drugs
- History of AIDS
- History of illicit drug abuse (defined as history of enrollment into a drug rehabilitation program or hospital visits due to drug use within the past 3 years or any use of the following drugs in the past 6 months (cocaine, opiates, amphetamines, marijuana) or any positive toxicology screen for (cocaine, opiates, amphetamines, marijuana)
- Too ill to participate in study based on investigator's or study team's opinion
- Current enrollment in another intervention trial
- In addition we amended our study with three additional criteria 11) systemic antibiotic use in the last 4 weeks, 12) use of probiotics and, 13) inflammatory bowel disease, four months after the start of the study and after 12 subjects were randomized, as we considered that these factors may also influence our study endpoints. Of the 12 subjects who were randomized, only 4 would have been excluded.
Sites / Locations
- Emory Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Other
Arm Label
Participants with vitamin D deficiency - treatment group
Participants with vitamin D deficiency - placebo group
Participants without vitamin D deficiency
Arm Description
Participants with 25-hydroxyvitamin D (25(OH)D) ≤30 ng/mL taking oral high-dose vitamin D3 (50,000 IU) once a week and providing stool and sputum sample at screening and 3 months after screening.
Participants with 25-hydroxyvitamin D (25(OH)D) concentrations ≤30 ng/mL taking a sham comparator (placebo) once a week and providing stool sample and sputum sample at screening and 3 months after screening.
Participants with 25-hydroxyvitamin D (25(OH)D) concentrations > 30 ng/mL with no intervention and providing stool sample and sputum sample at screening and 3 months after screening.
Outcomes
Primary Outcome Measures
Shannon Index
Sputum microbiota analysis will be measured using this ecological diversity measure. Sputum samples will be collected via a sputum kit.
Species Richness Index
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 Outcome Measures
Serum 25(OH)D levels (and other nutritional markers related to vitamin D including nutrient levels, parathyroid hormone, fibroblast growth factor-23, free 25(OH)D, vitamin D binding protein
Collected via blood draw.
Forced expiratory volume in 1 second (FEV1)
Spirometry (is a common office test used to assess how well the participant's lungs work by measuring how much air the participant inhales, how much the participant exhales and how quickly the participant exhales) to assess the impact of vitamin D status on lung function.
Spirometry results will only be collected if they are done as part of the participants routine care.
Measures of plasma oxidative stress by assessing plasma aminothiol concentrations (glutathione, glutathione disulfide, cysteine, cystine) and their redox potentials.
Collected via blood draw.
Measures of inflammation by assessing plasma IL-6, TNF-alpha, MCP-1, and IL-8 concentrations
Collected via blood draw.
Forced vital capacity (FVC)
Spirometry (is a common office test used to assess how well the participant's lungs work by measuring how much air the participant inhales, how much the participant exhales and how quickly the participant exhales) to assess the impact of vitamin D status on lung function.
Spirometry results will only be collected if they are done as part of the participants routine care.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02589444
Brief Title
Vitamin D and Microbiota in Cystic Fibrosis
Official Title
Pilot Study Evaluating the Role of Vitamin D Repletion on Gut and Lung Microbiota in Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to assess the effects of a high-dose vitamin D3 on the composition of gut and lung microbiota in adolescents and adults with cystic fibrosis who are vitamin D deficient.
Detailed Description
Monocentric, double-blind, randomized, placebo-controlled, interventional pilot study to investigate the beneficial effects of high dose vitamin D supplementation on gut and lung microbiota in patients with cystic fibrosis who are vitamin D insufficient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Cystic Fibrosis
Keywords
Clinical Endocrinology, Immunology, Inflammation, Microbiology, Respiratory Disorders, Vitamins
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants with vitamin D deficiency - treatment group
Arm Type
Experimental
Arm Description
Participants with 25-hydroxyvitamin D (25(OH)D) ≤30 ng/mL taking oral high-dose vitamin D3 (50,000 IU) once a week and providing stool and sputum sample at screening and 3 months after screening.
Arm Title
Participants with vitamin D deficiency - placebo group
Arm Type
Sham Comparator
Arm Description
Participants with 25-hydroxyvitamin D (25(OH)D) concentrations ≤30 ng/mL taking a sham comparator (placebo) once a week and providing stool sample and sputum sample at screening and 3 months after screening.
Arm Title
Participants without vitamin D deficiency
Arm Type
Other
Arm Description
Participants with 25-hydroxyvitamin D (25(OH)D) concentrations > 30 ng/mL with no intervention and providing stool sample and sputum sample at screening and 3 months after screening.
Intervention Type
Dietary Supplement
Intervention Name(s)
High-Dose Vitamin D3
Other Intervention Name(s)
Cholecalciferol
Intervention Description
50,000 IU of oral vitamin D3 once a week (the standard of care for repletion of vitamin D status by the Cystic fibrosis Foundation)
Intervention Type
Other
Intervention Name(s)
Stool Sample
Intervention Description
Participants will be asked to provide a stool sample in a collection container for analysis of stool microbiota. This will be done upon enrollment (baseline) and at 3 month follow-up.
Intervention Type
Other
Intervention Name(s)
Sputum Sample
Intervention Description
Participants will be asked to collect their sputum (the thick mucus or phlegm that is expelled from the lower respiratory tract through coughing) into a kit.
This will be done upon enrollment (baseline) and at 3 month follow-up.
Intervention Type
Other
Intervention Name(s)
Sham Comparator
Other Intervention Name(s)
Placebo
Intervention Description
A placebo capsule taken once a week (manufactured by the same company that makes the Vitamin D supplement).
Intervention Type
Procedure
Intervention Name(s)
Blood draw
Intervention Description
Participants will be asked to provide 30 ml of blood collected via a blood draw to measure 25 (OH)D serum concentration and other nutrient markers related to vitamin D including Parathyroid hormone, fibroblast growth factor-23, vitamin D binding protein and markers of immune system/inflammation. This will be done at baseline and at 3 months follow up.
Primary Outcome Measure Information:
Title
Shannon Index
Description
Sputum microbiota analysis will be measured using this ecological diversity measure. Sputum samples will be collected via a sputum kit.
Time Frame
Change from baseline shannon Index at 3 months after initiation of treatment
Title
Species Richness Index
Description
Stool microbiota analysis will be measured using this ecological diversity measure. Stool samples will be collected using a stool kit provided to the participant.
Time Frame
Change from baseline Species Richness Index at 3 months after initiation of treatment
Secondary Outcome Measure Information:
Title
Serum 25(OH)D levels (and other nutritional markers related to vitamin D including nutrient levels, parathyroid hormone, fibroblast growth factor-23, free 25(OH)D, vitamin D binding protein
Description
Collected via blood draw.
Time Frame
At baseline and 3 months after initiation of treatment
Title
Forced expiratory volume in 1 second (FEV1)
Description
Spirometry (is a common office test used to assess how well the participant's lungs work by measuring how much air the participant inhales, how much the participant exhales and how quickly the participant exhales) to assess the impact of vitamin D status on lung function.
Spirometry results will only be collected if they are done as part of the participants routine care.
Time Frame
Change in Forced expiratory volume in 1 second( FEV1) at 3 months after initiation of treatment
Title
Measures of plasma oxidative stress by assessing plasma aminothiol concentrations (glutathione, glutathione disulfide, cysteine, cystine) and their redox potentials.
Description
Collected via blood draw.
Time Frame
At baseline and 3 months after initiation of treatment
Title
Measures of inflammation by assessing plasma IL-6, TNF-alpha, MCP-1, and IL-8 concentrations
Description
Collected via blood draw.
Time Frame
At baseline and 3 months after initiation of treatment
Title
Forced vital capacity (FVC)
Description
Spirometry (is a common office test used to assess how well the participant's lungs work by measuring how much air the participant inhales, how much the participant exhales and how quickly the participant exhales) to assess the impact of vitamin D status on lung function.
Spirometry results will only be collected if they are done as part of the participants routine care.
Time Frame
Change in Forced vital capacity( FVC) at 3 months after initiation of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presenting to the Cystic fibrosis clinic for routine follow up of cystic fibrosis
Serum 25(OH)D concentrations obtained within 2 months of enrollment
Able to tolerate oral medications
Exclusion Criteria:
Inability to obtain or declined informed consent from the subject and/or legally authorized representative
Pregnancy or plans to become pregnant in the next 3 months
History of disorders associated with hypercalcemia including parathyroid disease
Current hypercalcemia (albumin-corrected serum calcium >10.8 mg/dL or ionized calcium >5.2 mg/dL)
History of nephrolithiasis with active symptoms within the past two years
Chronic kidney disease worse than stage III (<60 ml/min)
Current significant hepatic dysfunction total bilirubin > 2.5 mg/dL with direct bilirubin > 1.0 mg/dL
Current use of cytotoxic or immunosuppressive drugs
History of AIDS
History of illicit drug abuse (defined as history of enrollment into a drug rehabilitation program or hospital visits due to drug use within the past 3 years or any use of the following drugs in the past 6 months (cocaine, opiates, amphetamines, marijuana) or any positive toxicology screen for (cocaine, opiates, amphetamines, marijuana)
Too ill to participate in study based on investigator's or study team's opinion
Current enrollment in another intervention trial
In addition we amended our study with three additional criteria 11) systemic antibiotic use in the last 4 weeks, 12) use of probiotics and, 13) inflammatory bowel disease, four months after the start of the study and after 12 subjects were randomized, as we considered that these factors may also influence our study endpoints. Of the 12 subjects who were randomized, only 4 would have been excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vin Tangpricha, MD/PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29161417
Citation
Kanhere M, He J, Chassaing B, Ziegler TR, Alvarez JA, Ivie EA, Hao L, Hanfelt J, Gewirtz AT, Tangpricha V. Bolus Weekly Vitamin D3 Supplementation Impacts Gut and Airway Microbiota in Adults With Cystic Fibrosis: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial. J Clin Endocrinol Metab. 2018 Feb 1;103(2):564-574. doi: 10.1210/jc.2017-01983.
Results Reference
derived
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Vitamin D and Microbiota in Cystic Fibrosis
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