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Vitamin D and Microbiota in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT02589444
Recruitment Status : Completed
First Posted : October 28, 2015
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Vin Tangpricha, MD, PH.D, Emory University

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Cystic Fibrosis Dietary Supplement: High-Dose Vitamin D3 Other: Stool Sample Other: Sputum Sample Other: Sham Comparator Procedure: Blood draw Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Pilot Study Evaluating the Role of Vitamin D Repletion on Gut and Lung Microbiota in Cystic Fibrosis
Actual Study Start Date : December 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Participants with vitamin D deficiency - treatment group
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.
Dietary Supplement: High-Dose Vitamin D3
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)
Other Name: Cholecalciferol

Other: Stool Sample
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.

Other: Sputum Sample

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.


Procedure: Blood draw
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.

Sham Comparator: Participants with vitamin D deficiency - placebo group
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.
Other: Stool Sample
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.

Other: Sputum Sample

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.


Other: Sham Comparator
A placebo capsule taken once a week (manufactured by the same company that makes the Vitamin D supplement).
Other Name: Placebo

Procedure: Blood draw
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.

Participants without vitamin D deficiency
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.
Other: Stool Sample
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.

Other: Sputum Sample

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.


Procedure: Blood draw
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 Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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 ]
    Collected via blood draw.

  2. 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 ]

    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.


  3. 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 ]
    Collected via blood draw.

  4. 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 ]
    Collected via blood draw.

  5. Forced vital capacity (FVC) [ Time Frame: Change in Forced vital capacity( FVC) at 3 months after initiation of treatment ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02589444


Locations
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United States, Georgia
Emory Clinic
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Vin Tangpricha, MD/PhD Emory University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vin Tangpricha, MD, PH.D, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT02589444    
Other Study ID Numbers: IRB00083796
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Keywords provided by Vin Tangpricha, MD, PH.D, Emory University:
Clinical Endocrinology
Immunology
Inflammation
Microbiology
Respiratory Disorders
Vitamins
Additional relevant MeSH terms:
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Cystic Fibrosis
Vitamin D Deficiency
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents