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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with vitamin D deficiency - treatment group | Experimental | 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. |
|
| Participants with vitamin D deficiency - placebo group | Sham Comparator | 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. |
|
| Participants without vitamin D deficiency | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Dose Vitamin D3 | Dietary Supplement | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Shannon Index | Sputum microbiota analysis will be measured using this ecological diversity measure. Sputum samples will be collected via a sputum kit. | 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. | Change from baseline Species Richness Index at 3 months after initiation of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and 3 months after initiation of treatment |
| Forced expiratory volume in 1 second (FEV1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vin Tangpricha, MD/PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Clinic | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29161417 | Derived | Kanhere M, He J, Chassaing B, Ziegler TR, Alvarez JA, Ivie EA, Hao L, Hanfelt J, Gewirtz AT, Tangpricha V. Bolus Weekly Vitamin D3 Supplementation Impacts Gut and Airway Microbiota in Adults With Cystic Fibrosis: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial. J Clin Endocrinol Metab. 2018 Feb 1;103(2):564-574. doi: 10.1210/jc.2017-01983. |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D003550 | Cystic Fibrosis |
| D007249 | Inflammation |
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| Stool Sample | Other | 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. |
|
| Sputum Sample | Other | 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. |
|
| Sham Comparator | Other | A placebo capsule taken once a week (manufactured by the same company that makes the Vitamin D supplement). |
|
|
| Blood draw | Procedure | 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. |
|
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. |
| 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. | 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 | Collected via blood draw. | 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. | Change in Forced vital capacity( FVC) at 3 months after initiation of treatment |
| D009750 |
| Nutritional and Metabolic Diseases |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |