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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
41
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)
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.
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.
Emory Clinic
Atlanta, Georgia, United States
Shannon Index
Sputum microbiota analysis will be measured using this ecological diversity measure. Sputum samples will be collected via a sputum kit.
Time frame: Change from baseline shannon Index at 3 months after initiation of treatment
Species Richness Index
Stool microbiota analysis will be measured using this ecological diversity measure. Stool samples will be collected using a stool kit provided to the participant.
Time frame: Change from baseline Species Richness Index at 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
Collected via blood draw.
Time frame: At baseline and 3 months after initiation of treatment
Forced expiratory volume in 1 second (FEV1)
Spirometry (is a common office test used to assess how well the participant's lungs work by measuring how much air the participant inhales, how much the participant exhales and how quickly the participant exhales) to assess the impact of vitamin D status on lung function. Spirometry results will only be collected if they are done as part of the participants routine care.
Time frame: Change in Forced expiratory volume in 1 second( FEV1) 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.
Collected via blood draw.
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
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A placebo capsule taken once a week (manufactured by the same company that makes the Vitamin D supplement).
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.
Collected via blood draw.
Time frame: At baseline and 3 months after initiation of treatment
Forced vital capacity (FVC)
Spirometry (is a common office test used to assess how well the participant's lungs work by measuring how much air the participant inhales, how much the participant exhales and how quickly the participant exhales) to assess the impact of vitamin D status on lung function. Spirometry results will only be collected if they are done as part of the participants routine care.
Time frame: Change in Forced vital capacity( FVC) at 3 months after initiation of treatment