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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

Tracking Information
First Submitted Date  ICMJE October 20, 2015
First Posted Date  ICMJE October 28, 2015
Last Update Posted Date June 14, 2017
Actual Study Start Date  ICMJE December 2015
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2015)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2015)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D and Microbiota in Cystic Fibrosis
Official Title  ICMJE Pilot Study Evaluating the Role of Vitamin D Repletion on Gut and Lung Microbiota in Cystic Fibrosis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Vitamin D Deficiency
  • Cystic Fibrosis
Intervention  ICMJE
  • 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.

  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Dietary Supplement: High-Dose Vitamin D3
    • Other: Stool Sample
    • Other: Sputum Sample
    • Procedure: Blood draw
  • 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.
    Interventions:
    • Other: Stool Sample
    • Other: Sputum Sample
    • Other: Sham Comparator
    • Procedure: Blood draw
  • 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.
    Interventions:
    • Other: Stool Sample
    • Other: Sputum Sample
    • Procedure: Blood draw
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2017)
41
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2015)
60
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02589444
Other Study ID Numbers  ICMJE IRB00083796
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vin Tangpricha, MD, PH.D, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vin Tangpricha, MD/PhD Emory University
PRS Account Emory University
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP