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Vitamin D and Microbiota in Cystic Fibrosis

NCT02589444 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2017-06-14

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Vin Tangpricha, MD/PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-02-28
Completion
2017-04-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02589444 on ClinicalTrials.gov