Pilot Study Evaluating the Role of Vitamin D Repletion on Gut and Lung Microbiota in Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Shannon Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •In addition we amended our study with three additional criteria 11) systemic antibiotic use in the last 4 weeks, 12) use of probiotics and, 13) inflammatory bowel disease, four months after the start of the study and after 12 subjects were randomized, as we considered that these factors may also influence our study endpoints. Of the 12 subjects who were randomized, only 4 would have been excluded.
研究组 & 干预措施
Participants with vitamin D deficiency - treatment group
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.
干预措施: High-Dose Vitamin D3 (Dietary Supplement)
Participants with vitamin D deficiency - treatment group
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.
干预措施: Stool Sample (Other)
Participants with vitamin D deficiency - treatment group
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.
干预措施: Sputum Sample (Other)
Participants with vitamin D deficiency - treatment group
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.
干预措施: Blood draw (Procedure)
Participants with vitamin D deficiency - placebo group
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.
干预措施: Stool Sample (Other)
Participants with vitamin D deficiency - placebo group
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.
干预措施: Sputum Sample (Other)
Participants with vitamin D deficiency - placebo group
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.
干预措施: Sham Comparator (Other)
Participants with vitamin D deficiency - placebo group
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.
干预措施: Blood draw (Procedure)
Participants without vitamin D deficiency
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.
干预措施: Stool Sample (Other)
Participants without vitamin D deficiency
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.
干预措施: Sputum Sample (Other)
Participants without vitamin D deficiency
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.
干预措施: Blood draw (Procedure)
结局指标
主要结局
Shannon Index
时间窗: Change from baseline shannon Index at 3 months after initiation of treatment
Sputum microbiota analysis will be measured using this ecological diversity measure. Sputum samples will be collected via a sputum kit.
Species Richness Index
时间窗: Change from baseline Species Richness Index at 3 months after initiation of treatment
Stool microbiota analysis will be measured using this ecological diversity measure. Stool samples will be collected using a stool kit provided to the participant.
次要结局
- 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(At baseline and 3 months after initiation of treatment)
- Forced expiratory volume in 1 second (FEV1)(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.(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(At baseline and 3 months after initiation of treatment)
- Forced vital capacity (FVC)(Change in Forced vital capacity( FVC) at 3 months after initiation of treatment)
研究者
Vin Tangpricha, MD, PH.D
Associate Professor
Emory University