Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis
2015年7月20日 更新者:Michael O'Connor、Vanderbilt University
Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis: Effects on Exhaled Pro-inflammatory Isoprostanes and Analysis of Its Esterification Sites in Plasma
Oral supplementation of patients affected by cystic fibrosis with docosahexanoic acid (DHA) will result in normalization of the known fatty acid derangements in these patients and will diminish the production of proinflammatory isoprostanes such as 8-isoprostane-PGF2α.
研究概览
详细说明
The study design will be a single-center, randomized, placebo-controlled, cross-over trial.
After informed consent has been obtained, 18 eligible subjects with pancreatic insufficient cystic fibrosis will be enrolled in the study.
Participants will take part in two 4 week study sessions, each separated by a 4 week washout period.
One session will involve treatment with placebo and the other two sessions will provide treatment with approximately 25mg and 35 mg of DHA/kg of body weight.
The patients will be assigned to each of the treatment sessions in random order, as described above.
The DHA source will be provided by Martek Biosciences Corporation, Columbia, MD, USA in the form of a chewable capsule containing 200 mg of DHA.
The placebos will be identical to the DHA supplement but will not contain the active ingredient, DHA.
Subjects will be instructed to take the study capsules in addition to their normal doses of pancreatic enzymes with meals and to maintain their usual diets.
Blood, urine, and exhaled breath condensate samples will be collected at baseline and after completion of each of the study periods.
Patients will be screened and enrolled when they present to clinic for their routine check-up.
The subjects have routine blood work at their annual check-ups, and when possible will have an additional tube of blood saved for the baseline fatty acid profiles so as to avoid unnecessary blood draws.
Following each study period, blood draw, urine collection, and exhaled breath condensate (EBC) will be collected at the Vanderbilt Clinical Research Center.
The patients will also be given the supply of DHA and placebo (for the entire study) at time of enrollment.
The order in which they take the supplement or the placebo will be determined using a randomization table.
研究类型
介入性
注册 (实际的)
17
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Tennessee
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Nashville、Tennessee、美国、37232
- Vanderbilt University Medical Center
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
6年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Diagnosis of Cystic Fibrosis based on sweat chloride value > 60 mEq/L or genotyping
- Pancreatic insufficiency, defined by requirement for treatment with exogenous pancreatic enzymes
- FEV 1 > 40
- Less than 3 pulmonary exacerbations in the last year (as diagnosed by pulmonary attending physician)
- Age greater than 6 years
- Capability of performing pulmonary function tests
- Ability to swallow gel capsule
- Ability to comply with medication use, study visits, and study procedures
- Written informed consent obtained from subject or study subject's legal representative
Exclusion Criteria:
- Presence of severe CF-related liver disease, including SGOT or SGPT>3 times the normal limits, history of biliary cirrhosis, or portal hypertension
- Severe pulmonary disease, as defined by FEV1 < 40%
- Elevated serum creatinine or BUN
- Pregnancy
- PT >1.5 time normal
- Diabetes mellitus
- Daily use of NSAIDs or other anticoagulants
- History of fish allergy
- Use of ticlopidine, clopidogrel, dipyridamole
- Use of glucocorticoids
- History of lung transplant or currently on lung transplantation list
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the subject or the quality of the data
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Docosahexanoic Acid Supplement
In this arm, participants took two different doses of a DHA supplement.
Each dose of the DHA supplement was taken for 4 weeks.
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The active treatment will consist of Martek's chewable DHA capsules containing 200mg in each capsule. The treatment will be provided as approximately 25mg/kg/day and 35mg/kg/day. These dosages will be divided BID-TID and will be given for 4 weeks.
其他名称:
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安慰剂比较:Placebo
In this arm, participants took a placebo pill that did not contain any DHA.
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Placebo identical to active treatment.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Exhaled breath 8-isoprostane-PGFα and urine 8-isoprostane-PGFα
大体时间:4 measurements: baseline and then one measurement after each of the three 4-week study periods
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4 measurements: baseline and then one measurement after each of the three 4-week study periods
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次要结果测量
结果测量 |
大体时间 |
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Fatty acid profile analysis including esterification sites in plasma
大体时间:4 measurements - Baseline and then one measurement after each of the three 4-week study periods
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4 measurements - Baseline and then one measurement after each of the three 4-week study periods
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Michael G O'Connor, MD、Vanderbilt University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年11月1日
初级完成 (实际的)
2015年5月1日
研究完成 (实际的)
2015年7月1日
研究注册日期
首次提交
2009年6月17日
首先提交符合 QC 标准的
2009年6月17日
首次发布 (估计)
2009年6月19日
研究记录更新
最后更新发布 (估计)
2015年7月21日
上次提交的符合 QC 标准的更新
2015年7月20日
最后验证
2015年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Docosahexanoic Acid Supplement的临床试验
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Gladwin, Mark, MDNational Heart, Lung, and Blood Institute (NHLBI); Complexa, Inc.终止
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University College, LondonImperial College London; Cancer Research UK; National Cancer Imaging Translational Accelerator招聘中
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University of Colorado, DenverNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)招聘中
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Critical Outcome Technologies Inc.M.D. Anderson Cancer Center; Northwestern Memorial Hospital未知宫颈癌 | 头颈癌 | 大肠癌 | 胰腺癌 | 卵巢癌 | 输卵管癌 | 肺癌 | 子宫内膜癌 | 腹膜癌 | HNSCC美国