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Vitamin D and Microbiota in Cystic Fibrosis

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Disease Information

Descriptive Information
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
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 Phase N/A
Study Type † Interventional
Study Design †
Primary Outcome Measure † Shannon Index
Secondary Outcome Measure † 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
Condition † Vitamin D Deficiency Cystic Fibrosis
Intervention † Dietary SupplementHigh-Dose Vitamin D3
Study Arms / Comparison Groups 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. 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. 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.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Dietary Supplement
Estimated Enrollment † 41
Start Date † December 2015
Completion Date April 2017
Primary Completion Date February 2017
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 ( 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.
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT02589444
Organization ID IRB00083796
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Emory University
Collaborators ††
Investigators † Principal Investigator: Vin Tangpricha, MD/PhD, Emory University
Information Provided By
Verification Date June 2017
First Received Date † October 20, 2015
Last Updated Date June 10, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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