Vitamin D and Microbiota in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Pilot Study Evaluating the Role of Vitamin D Repletion on Gut and Lung Microbiota in Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02589444
• Other study ID #: IRB00083796
• Status: Completed
• Phase: N/A
• First received: October 20, 2015
• Last updated: June 10, 2017
• Start date: December 2015
• Est. completion date: April 2017

Study information

• Verified date: June 2017
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Vitamin D Deficiency

Intervention

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

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.

Locations

Country	Name	City	State
United States	Emory Clinic	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shannon Index	Sputum microbiota analysis will be measured using this ecological diversity measure. Sputum samples will be collected via a sputum kit.	Change from baseline shannon Index at 3 months after initiation of treatment
Primary	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.	Change from baseline Species Richness Index at 3 months after initiation of treatment
Secondary	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.	At baseline and 3 months after initiation of treatment
Secondary	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.	Change in Forced expiratory volume in 1 second( FEV1) at 3 months after initiation of treatment
Secondary	Measures of plasma oxidative stress by assessing plasma aminothiol concentrations (glutathione, glutathione disulfide, cysteine, cystine) and their redox potentials.	Collected via blood draw.	At baseline and 3 months after initiation of treatment
Secondary	Measures of inflammation by assessing plasma IL-6, TNF-alpha, MCP-1, and IL-8 concentrations	Collected via blood draw.	At baseline and 3 months after initiation of treatment
Secondary	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.	Change in Forced vital capacity( FVC) at 3 months after initiation of treatment