Vitamin D and Microbiota in Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02589444
• Date of registration: 20/10/2015
• Prospective Registration: Yes
• Primary sponsor: Emory University
• Public title: Vitamin D and Microbiota in Cystic Fibrosis
• Scientific title: Pilot Study Evaluating the Role of Vitamin D Repletion on Gut and Lung Microbiota in Cystic Fibrosis
• Date of first enrolment: December 2015
• Target sample size: 41
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02589444
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Vin Tangpricha, MD/PhD
• Affiliation: Emory University

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Vitamin D Deficiency

Intervention(s)

Dietary Supplement: High-Dose Vitamin D3

Other: Sputum Sample

Other: Sham Comparator

Procedure: Blood draw

Other: Stool Sample

Primary Outcome(s)

Species Richness Index [Time Frame: Change from baseline Species Richness Index at 3 months after initiation of treatment]

Shannon Index [Time Frame: Change from baseline shannon Index at 3 months after initiation of treatment]

Secondary Outcome(s)

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]

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

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]

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]

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]

Secondary ID(s)

IRB00083796

Source(s) of Monetary Support

Please refer to primary and secondary sponsors