Vitamin D and Microbiota in Cystic Fibrosis

Emory University

Status: Completed

Conditions: Vitamin D Deficiency; Cystic Fibrosis

Treatments: Other: Stool Sample; Other: Sham Comparator; Procedure: Blood draw; Other: Sputum Sample; Dietary Supplement: High-Dose Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT02589444

IRB00083796

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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41 participants in 3 patient groups

Participants with vitamin D deficiency - treatment group

Experimental group

Description:

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.

Treatment:

Procedure: Blood draw

Dietary Supplement: High-Dose Vitamin D3

Other: Sputum Sample

Other: Stool Sample

Participants with vitamin D deficiency - placebo group

Sham Comparator group

Description:

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.

Treatment:

Procedure: Blood draw

Other: Sputum Sample

Other: Sham Comparator

Other: Stool Sample

Participants without vitamin D deficiency

Other group

Description:

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.

Treatment:

Procedure: Blood draw

Other: Sputum Sample

Other: Stool Sample