Vitamin D DeficiencyNCT02589444
Vitamin D and Microbiota in Cystic Fibrosis
A study testing High-Dose Vitamin D3, Stool Sample and Sputum Sample in people with Vitamin D Deficiency and Cystic Fibrosis, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Deficiency, Cystic Fibrosis
- What is being tested?
- High-Dose Vitamin D3, Stool Sample and Sputum Sample
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study Evaluating the Role of Vitamin D Repletion on Gut and Lung Microbiota in Cystic Fibrosis
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.
Read the 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.
- Conditions
- Vitamin D Deficiency, Cystic Fibrosis
- Being tested
- High-Dose Vitamin D3, Stool Sample, Sputum Sample, Sham Comparator, Blood draw
- Keywords
- Clinical Endocrinology, Immunology, Inflammation, Microbiology, Respiratory Disorders, Vitamins
- Medical subject headings
- Vitamin D Deficiency, Cystic Fibrosis, Inflammation, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Dose Vitamin D3Dietary supplement
Also called Cholecalciferol
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)
Stool SampleOther
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.
Sputum SampleOther
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.
Sham ComparatorOther
Also called Placebo
A placebo capsule taken once a week (manufactured by the same company that makes the Vitamin D supplement).
Blood drawProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with vitamin D deficiency - treatment group | Experimental | 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. Receives: Dietary Supplement: High-Dose Vitamin D3; Other: Stool Sample; Other: Sputum Sample; Procedure: Blood draw |
| Participants with vitamin D deficiency - placebo group | Sham comparator | 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. Receives: Other: Stool Sample; Other: Sputum Sample; Other: Sham Comparator; Procedure: Blood draw |
| Participants without vitamin D deficiency | Other | 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. Receives: Other: Stool Sample; Other: Sputum Sample; Procedure: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shannon Index
Sputum microbiota analysis will be measured using this ecological diversity measure. Sputum samples will be collected via a sputum kit.
Measured: Change from baseline shannon Index at 3 months after initiation of treatment
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.
Measured: Change from baseline Species Richness Index at 3 months after initiation of treatment
Secondary outcomes (5)
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.
Measured: At baseline and 3 months after initiation of treatment
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.
Measured: Change in Forced expiratory volume in 1 second( FEV1) at 3 months after initiation of treatment
Measures of plasma oxidative stress by assessing plasma aminothiol concentrations (glutathione, glutathione disulfide, cysteine, cystine) and their redox potentials.
Collected via blood draw.
Measured: At baseline and 3 months after initiation of treatment
Measures of inflammation by assessing plasma IL-6, TNF-alpha, MCP-1, and IL-8 concentrations
Collected via blood draw.
Measured: At baseline and 3 months after initiation of treatment
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.
Measured: Change in Forced vital capacity( FVC) at 3 months after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startDec 2015
- Primary completionFeb 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vin Tangpricha, MD, PH.D, Emory University
- Investigators
- Vin Tangpricha, MD/PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589444
- Sponsor's protocol ID
- IRB00083796
- Status last verified
- Jun 2017
- First submitted
- 20 Oct 2015
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29161417
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating the Role of Vitamin D Repletion on Gut and Lung Microbiota in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02589444
- Acronym / sponsor ID
- IRB00083796
- Conditions
- Vitamin D Deficiency, Cystic Fibrosis
- Keywords
- Clinical Endocrinology, Immunology, Inflammation, Microbiology, Respiratory Disorders, Vitamins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants with vitamin D deficiency - treatment group | Experimental | Dietary Supplement: High-Dose Vitamin D3, Other: Stool Sample, Other: Sputum Sample, Procedure: Blood drawParticipants 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 vitamin D deficiency - placebo group | Sham comparator | Other: Stool Sample, Other: Sputum Sample, Other: Sham Comparator, Procedure: Blood drawParticipants 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 without vitamin D deficiency | Other | Other: Stool Sample, Other: Sputum Sample, Procedure: Blood drawParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Dose Vitamin D3Also: Cholecalciferol50,000 IU of oral vitamin D3 once a week (the standard of care for repletion of vitamin D status by the Cystic fibrosis Foundation) | Dietary supplement | Participants with vitamin D deficiency - treatment group |
| Stool SampleParticipants 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. | Other | Participants with vitamin D deficiency - placebo group, Participants with vitamin D deficiency - treatment group, Participants without vitamin D deficiency |
| Sputum SampleParticipants 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. | Other | Participants with vitamin D deficiency - placebo group, Participants with vitamin D deficiency - treatment group, Participants without vitamin D deficiency |
| Sham ComparatorAlso: PlaceboA placebo capsule taken once a week (manufactured by the same company that makes the Vitamin D supplement). | Other | Participants with vitamin D deficiency - placebo group |
| Blood drawParticipants 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. | Procedure or surgery | Participants with vitamin D deficiency - placebo group, Participants with vitamin D deficiency - treatment group, Participants without vitamin D deficiency |
Primary outcome
Shannon Index
Time frame: Change from baseline shannon Index at 3 months after initiation of treatment
Sputum microbiota analysis will be measured using this ecological diversity measure. Sputum samples will be collected via a sputum kit.
Species Richness Index
Time frame: Change from baseline Species Richness Index at 3 months after initiation of treatment
Stool microbiota analysis will be measured using this ecological diversity measure. Stool samples will be collected using a stool kit provided to the participant.
5 secondary outcomes
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
Time frame: At baseline and 3 months after initiation of treatment
Forced expiratory volume in 1 second (FEV1)
Time frame: Change in Forced expiratory volume in 1 second( FEV1) at 3 months after initiation of treatment
Measures of plasma oxidative stress by assessing plasma aminothiol concentrations (glutathione, glutathione disulfide, cysteine, cystine) and their redox potentials.
Time frame: At baseline and 3 months after initiation of treatment
Measures of inflammation by assessing plasma IL-6, TNF-alpha, MCP-1, and IL-8 concentrations
Time frame: At baseline and 3 months after initiation of treatment
Forced vital capacity (FVC)
Time frame: Change in Forced vital capacity( FVC) at 3 months after initiation of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Derived from this study: PubMed 29161417Kanhere 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.
Related trials for Vitamin D Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vin Tangpricha, MD/PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Dose Vitamin D3, Stool Sample and Sputum Sample in people with Vitamin D Deficiency and Cystic Fibrosis, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shannon Index (time frame: Change from baseline shannon Index at 3 months after initiation of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02589444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.