The Chronic Obstructive Pulmonary Disease Fish Oil Pilot Trial

NCT00835289 | Completed DMC

• 2 other identifiers: AAAC9586P30ES009089
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Clinical Trials, Randomized

Outcome Measures

Primary Outcomes (1)

• Percent Flow Mediated Dilation (FMD)

  6 months

Secondary Outcomes (8)

• Serum level of LTB4

  6 months

• Serum level of TNF-alpha

  6 months

• Serum level of IFN-gamma

  6 months

• Difference in Pre- and Post-bronchodilator Spirometry

  6 months

• Average six-minute-walk test distance

  6 months

Study Arms (2)

Placebo (corn oil)

PLACEBO COMPARATOR

Each participant will be taking 3 capsules of a matching placebo (corn oil).

Other: Placebo

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\[TM\].

Dietary Supplement: n-3 polyunsaturated fatty acids

Interventions

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.

Also known as: Omax-3, PUFA, Omega-3

PUFA (Omax3)

Placebo OTHER

3 capsules of matching corn oil placebo

Placebo (corn oil)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-bronchodilator FEV1/FVC ratio \<70%
• Post-bronchodilator FEV1 \<65% predicted.
• Clinical diagnosis of COPD
• Stable medical regimen for 30 days prior to enrollment
• Age \> 40 years old
• History of former cigarette smoking, \> or = 10 pack years

You may not qualify if:

• COPD exacerbation or hospitalization for COPD in the past 30 days
• Confirmed history of physician-diagnosed asthma
• History of unrelated pulmonary disease (e.g. interstitial lung disease, thromboembolic disease)
• Status-post lung transplantation or Lung volume reduction surgery (LVRS)
• Systolic blood pressure \>170mmHg or\<100mmHg at rest, diastolic blood pressure \>100 at rest, or resting HR \>120.
• Active cigarette smoking
• Clinical diagnosis of left-sided congestive heart failure
• Clinical diagnosis of coronary artery disease
• Clinical diagnosis of cerebrovascular disease
• Clinical diagnosis of peripheral vascular disease
• Prior history of stroke or myocardial infarction
• Clinical diagnosis of obstructive sleep apnea
• Pregnancy (known, and screen with urine BHCG) or current breastfeeding
• Contraindication to Omax3\[TM\] use, including a history of hypersensitivity to Omax3\[TM\]
• Current use of high-dose fish oil capsules (defined as \>1 or 2 grams/day of omega-3 fatty acids)

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 33150779 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fatty Acids, Omega-3; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• R Graham Barr, MD/DrPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: February 3, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

US (1)