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| ID | Type | Description | Link |
|---|---|---|---|
| P30ES009089 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
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Chronic obstructive pulmonary disease (COPD) is currently the fourth leading cause of death in the United States. Unlike the other leading causes of death, no medical therapies currently available improve the course of disease or affect survival in COPD. Recent investigations suggest that endothelial dysfunction and chronic inflammation is fundamental to COPD. Fish oil intake improves endothelial dysfunction and lowers levels of inflammatory intermediaries which may be important in the development of COPD.
The Chronic Obstructive Pulmonary Disease Fish Oil (COD-Fish) Pilot Trial will enroll 40-45 participants with COPD. These participants will be randomized to receive omega-3 polyunsaturated fatty acid supplementation (PUFA) or placebo (containing corn oil). All participants will perform a number of noninvasive tests (including flow-mediated dilation (FMD) and pulmonary function testing) at study entry as well as every two months for a total of six months. Thirty participants who agree to it will undergo a separate procedure to collect cells from inside a forearm vein for analysis to be compared to 30 controls. The main purpose of this trial is to examine the effect of PUFA on endothelial function as measured by change in FMD in patients with COPD. We hypothesize that in subjects with COPD, treatment with PUFA will increase FMD.
Chronic obstructive pulmonary disease is abbreviated as COPD and includes both emphysema and chronic bronchitis. COPD is currently the fourth leading cause of death in the United States. Unlike most major medical diseases, the morbidity and mortality from COPD continue to rise in the US. In 2000, over 10 million Americans carried a physician diagnosis of COPD and 120,000 Americans died from this disease. Additionally, from the year 1980 to the year 2000, the number of cases of COPD among women nearly doubled and the prevalence among African Americans increased by 61%. Unlike the other leading causes of death, no medical therapies currently available improve the course of disease or affect survival in COPD. Current therapies for COPD that improve survival in COPD are limited to smoking cessation, oxygen therapy, and possibly surgery. Medical therapies such as inhalers and pills improve symptoms and reduce COPD exacerbations ("attacks"), but have not been shown to slow down the progression of the disease.
Recent investigations suggest that endothelial dysfunction and chronic inflammation is fundamental to COPD. Fish oil intake improves endothelial dysfunction and lowers levels of inflammatory intermediaries. These inflammatory intermediaries can be measured in the blood and are potentially important in the development of COPD. Large observational studies demonstrate that participants who eat high amounts of fish oil develop less COPD and have lower levels of these inflammatory intermediaries.
The Chronic Obstructive Pulmonary Disease Fish Oil (COD-Fish) Pilot Trial will enroll 40-45 participants with COPD. These participants will be randomized to receive Omax3[TM] or placebo (containing corn oil). Omax3[TM] (Cenestra Health) is a 1 gram softgel capsule containing 94.5% omega-3 fatty acids. Each participant will be taking 3 capsules of either Omax3[TM] or matching placebo. The investigators and the subjects will be blinded, meaning that neither the investigators nor the subjects will know if they are taking Omax3[TM] or placebo. All participants will perform a number of noninvasive tests at study entry as well as every two months for a total of six months. They will also undergo pulmonary function testing, flow-mediated dilation (FMD), peripheral arterial tonometry (PAT), six minute-walk tests (6MWT), blood drawing and answer questionnaire data. Thirty participants who agree to it will undergo a separate procedure to collect cells from inside a forearm vein for analysis to be compared to 30 controls. The main purpose of this trial is to examine the effect of Omax3[TM] on endothelial function as measured by change in FMD in patients with COPD. We hypothesize that in subjects with COPD, treatment with Omax3[TM] will increase FMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (corn oil) | Placebo Comparator | Each participant will be taking 3 capsules of a matching placebo (corn oil). |
|
| PUFA (Omax3) | Experimental | Omax3[TM] (Cenestra Health), or dietary supplement: n-3 polyunsaturated fatty acids, is a 1 gram softgel capsule containing 94.5% omega-3 fatty acids. Each participant will be taking 3 capsules of Omax3[TM]. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| n-3 polyunsaturated fatty acids | Dietary Supplement | Omax3[TM] (Cenestra Health [TM]) is a 1 g softgel capsule containing 94.5% omega-3 fatty acids. Each serving size is a 1 gram capsule, which contains 690 mg of eicosapentanoic acid (EPA) and 182 mg of docosahexanoic acid (DHA). Inactive ingredients include: Vitamin E/Tocopherol 2294 ppm (in a carrier of partially hydrogenated vegetable oils including soybean oil), gelatin, glycerol, and purified water (components of the capsule shell). The study participants will be randomized to 3 softgel capsules a day for 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Flow Mediated Dilation (FMD) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum level of LTB4 | 6 months | |
| Serum level of TNF-alpha | 6 months | |
| Serum level of IFN-gamma |
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Inclusion Criteria:
Exclusion Criteria:
For Non-COPD controls (Same Inclusion and exclusion criteria, except for inclusion, must NOT have the following:)
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| Name | Affiliation | Role |
|---|---|---|
| R Graham Barr, MD/DrPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33150779 | Result | Kim JS, Thomashow MA, Yip NH, Burkart KM, Lo Cascio CM, Shimbo D, Barr RG. Randomization to Omega-3 Fatty Acid Supplementation and Endothelial Function in COPD: The COD-Fish Randomized Controlled Trial. Chronic Obstr Pulm Dis. 2021 Jan;8(1):41-53. doi: 10.15326/jcopdf.8.1.2020.0132. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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|
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| Placebo | Other | 3 capsules of matching corn oil placebo |
|
| 6 months |
| Difference in Pre- and Post-bronchodilator Spirometry | 6 months |
| Average six-minute-walk test distance | 6 months |
| Average St. George's Respiratory Questionnaire score | 6 months |
| Change in percent of Peripheral Arterial Tonometry (EndoPAT) | 4 months |
| Number of endothelial cell protein expression | 6 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |