Vitamin D and Microbiota in Cystic Fibrosis

Not Applicable

Completed

• Conditions: Vitamin D Deficiency; Cystic Fibrosis
• Interventions: Dietary Supplement: High-Dose Vitamin D3; Other: Sputum Sample; Other: Stool Sample; Other: Sham Comparator; Procedure: Blood draw

• Registration Number: NCT02589444
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Study Start: 2015-12
• Primary Completion: 2017-02
• Study Completion: 2017-04
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-10
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants with vitamin D deficiency - treatment group	High-Dose Vitamin D3	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 - treatment group	Blood draw	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	Sputum Sample	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	Blood draw	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.
Participants with vitamin D deficiency - treatment group	Stool Sample	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	Blood draw	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 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.
Participants without vitamin D deficiency	Stool Sample	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.
Participants without vitamin D deficiency	Sputum Sample	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.
Participants with vitamin D deficiency - treatment group	Sputum Sample	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	Stool Sample	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.

Primary Outcome Measures

Name	Time	Method
Shannon Index	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	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

Name	Time	Method
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	At baseline and 3 months after initiation of treatment	Collected via blood draw.
Forced expiratory volume in 1 second (FEV1)	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.	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	At baseline and 3 months after initiation of treatment	Collected via blood draw.
Forced vital capacity (FVC)	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.

Trial Locations

Locations (1)

Emory Clinic; 🇺🇸 Atlanta, Georgia, United States