Expired Study
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Atlanta, Georgia 30322


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT02589444


Primary Contact:

Principal Investigator
Vin Tangpricha, MD/PhD
Emory University


Backup Contact:

N/A


Location Contact:

Atlanta, Georgia 30322
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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