Vitamin D and Microbiota in Cystic Fibrosis

NACompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

February 28, 2017

Study Completion Date

April 30, 2017

Conditions
Vitamin D DeficiencyCystic Fibrosis
Interventions
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.

OTHER

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."

OTHER

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.

Trial Locations (1)

30322

Emory Clinic, Atlanta

All Listed Sponsors
lead

Emory University

OTHER

NCT02589444 - Vitamin D and Microbiota in Cystic Fibrosis | Biotech Hunter | Biotech Hunter