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The Effects of DHA on Periodontitis (DAP)

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ClinicalTrials.gov Identifier: NCT01976806
Recruitment Status : Completed
First Posted : November 6, 2013
Results First Posted : March 24, 2014
Last Update Posted : December 13, 2017
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
Harvard Medical School
Information provided by (Responsible Party):
Kenneth Mukamal, Beth Israel Deaconess Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Periodontitis
Gingivitis
Inflammation
Interventions: Drug: Aspirin
Drug: Docosahexaenoic acid
Drug: Placebo (for Docosahexaenoic acid)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Aspirin & Docosahexaenoic Acid

Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months

Aspirin

Docosahexaenoic acid

Aspirin & Placebo

Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months

Aspirin

Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules


Participant Flow:   Overall Study
    Aspirin & Docosahexaenoic Acid   Aspirin & Placebo
STARTED   27   28 
COMPLETED   24   22 
NOT COMPLETED   3   6 
Lost to Follow-up                1                4 
Adverse Event                1                1 
Withdrawal by Subject                1                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes all subjects that completed follow-up

Reporting Groups
  Description
Aspirin & Docosahexaenoic Acid

Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months

Aspirin

Docosahexaenoic acid

Aspirin & Placebo

Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months

Aspirin

Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules

Total Total of all reporting groups

Baseline Measures
   Aspirin & Docosahexaenoic Acid   Aspirin & Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   22   46 
Age 
[Units: Years]
Mean (Standard Deviation)
 53  (8)   57  (8)   55  (8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11  45.8%      10  45.5%      21  45.7% 
Male      13  54.2%      12  54.5%      25  54.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      4  16.7%      1   4.5%      5  10.9% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      7  29.2%      8  36.4%      15  32.6% 
White      12  50.0%      12  54.5%      24  52.2% 
More than one race      0   0.0%      1   4.5%      1   2.2% 
Unknown or Not Reported      1   4.2%      0   0.0%      1   2.2% 
Smoking Status 
[Units: Participants]
     
Current   1   1   2 
Former   7   6   13 
Never   16   15   31 
BMI (kg/m2) 
[Units: Participants]
     
Normal (18.5-24.9 kg/m2)   9   5   14 
Overweight (25-30 kg/m2)   4   10   14 
Obese (>30 kg/m2)   11   7   18 
Hypertension 
[Units: Participants]
     
Hypertension   4   6   10 
No Hypertension   20   16   36 
Hyperlipidemia 
[Units: Participants]
     
Hyperlipidemia   5   4   9 
No Hyperlipidemia   19   18   37 


  Outcome Measures

1.  Primary:   Change in Pocket Depth (mm)   [ Time Frame: Baseline and 3 months ]

Measure Type Primary
Measure Title Change in Pocket Depth (mm)
Measure Description Pocket probing depth (PD) is the depth a dental probe can be inserted into a gingival pocket at a particular site (6 sites per tooth) measured in millimeters among teeth with PD greater than or equal to 5 mm (N=533 dental sites total).
Time Frame Baseline and 3 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Aspirin & Docosahexaenoic Acid

Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months

Aspirin

Docosahexaenoic acid

Aspirin & Placebo

Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months

Aspirin

Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules


Measured Values
   Aspirin & Docosahexaenoic Acid   Aspirin & Placebo 
Participants Analyzed   24   22 
Change in Pocket Depth (mm) 
[Units: Mm]
Mean (Standard Error)
 -0.71  (0.07)   -0.54  (0.07) 


Statistical Analysis 1 for Change in Pocket Depth (mm)
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] <0.05
Mean Difference (Net) [5] -0.29
Standard Error of the Mean (0.13)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Intent-to-treat basis with a type I error rate of 0.05. The follow-up pocket depth, was assessed in linear mixed effects models with a compound-symmetry covariance structure and age, sex, BMI, race, baseline pocket depth, baseline red blood cell (RBC) DHA level (dichotomized at median), and intervention group as fixed-effect variables.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Compound-symmetry covariance structure with age, sex, BMI, race, baseline pocket depth, baseline RBC DHA level, and intervention group variables
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  Mean change in pocket depth (3-month follow-up minus baseline) among dental sites with baseline pocket depths >=5 mm in the DHA intervention group versus the placebo group.



2.  Secondary:   Change in Gingival Index (0-3)   [ Time Frame: Baseline and 3 months ]

Measure Type Secondary
Measure Title Change in Gingival Index (0-3)
Measure Description

Gingival Index (GI) is a measure of gingival inflammation, which is assigned a score (0-3).

Score Criteria:

0: No inflammation.

  1. Mild inflammation, slight change in color, slight edema, no bleeding on probing.
  2. Moderate inflammation, moderate glazing, redness, bleeding on probing.
  3. Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.
Time Frame Baseline and 3 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Aspirin & Docosahexaenoic Acid

Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months

Aspirin

Docosahexaenoic acid

Aspirin & Placebo

Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months

Aspirin

Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules


Measured Values
   Aspirin & Docosahexaenoic Acid   Aspirin & Placebo 
Participants Analyzed   24   22 
Change in Gingival Index (0-3) 
[Units: GI units]
Mean (Standard Error)
 -0.26  (0.04)   -0.07  (0.04) 

No statistical analysis provided for Change in Gingival Index (0-3)



3.  Secondary:   Change in Plaque Index (0-3)   [ Time Frame: Baseline and 3 months ]

Measure Type Secondary
Measure Title Change in Plaque Index (0-3)
Measure Description

Plaque Index (PI) is a measure of gingival inflammation as induced by bacterial plaque deposition at and under the gum line.

Score Criteria:

0: No plaque

  1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which can not be seen with the naked eye. But only by using disclosing solution or by using probe.
  2. Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye.
  3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Time Frame Baseline and 3 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Aspirin & Docosahexaenoic Acid

Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months

Aspirin

Docosahexaenoic acid

Aspirin & Placebo

Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months

Aspirin

Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules


Measured Values
   Aspirin & Docosahexaenoic Acid   Aspirin & Placebo 
Participants Analyzed   24   22 
Change in Plaque Index (0-3) 
[Units: Plaque index units]
Mean (Standard Error)
 -0.10  (0.06)   0.07  (0.07) 

No statistical analysis provided for Change in Plaque Index (0-3)



4.  Secondary:   Sites With Bleeding on Probing (Yes/no)   [ Time Frame: 3 months ]

Measure Type Secondary
Measure Title Sites With Bleeding on Probing (Yes/no)
Measure Description Bleeding On Probing (BOP) is a measure of gingival inflammation and tissue destruction, which describes whether or not bleeding at the dental pocket occurred following probing.
Time Frame 3 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results presented at 3 months; 3-months results also compared to baseline BOP using logistic regression as described in manuscript.

Reporting Groups
  Description
Aspirin & Docosahexaenoic Acid

Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months

Aspirin

Docosahexaenoic acid

Aspirin & Placebo

Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months

Aspirin

Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules


Measured Values
   Aspirin & Docosahexaenoic Acid   Aspirin & Placebo 
Participants Analyzed   24   22 
Units Analyzed (Sites)   271   261 
Sites With Bleeding on Probing (Yes/no) 
[Units: Sites]
Count of Units
 202   227 

No statistical analysis provided for Sites With Bleeding on Probing (Yes/no)



5.  Secondary:   Gingival Crevicular Fluid High Sensitivity C-reactive Protein   [ Time Frame: Baseline and 3 months ]

Measure Type Secondary
Measure Title Gingival Crevicular Fluid High Sensitivity C-reactive Protein
Measure Description Gingival crevicular fluid (GCF) is the fluid bathing the teeth under the gum line. GCF samples were analyzed for high sensitivity C-reactive protein as a measure of local gingival inflammation.
Time Frame Baseline and 3 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected.

Reporting Groups
  Description
Aspirin & Docosahexaenoic Acid

Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months

Aspirin

Docosahexaenoic acid

Aspirin & Placebo

Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months

Aspirin

Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules


Measured Values
   Aspirin & Docosahexaenoic Acid   Aspirin & Placebo 
Participants Analyzed   20   19 
Gingival Crevicular Fluid High Sensitivity C-reactive Protein 
[Units: ng/mL]
Mean (Standard Error)
 -7.3715  (3.9244)   -3.1268  (2.0415) 

No statistical analysis provided for Gingival Crevicular Fluid High Sensitivity C-reactive Protein



6.  Secondary:   Gingival Crevicular Fluid Interleukin-6   [ Time Frame: Baseline and 3 months ]

Measure Type Secondary
Measure Title Gingival Crevicular Fluid Interleukin-6
Measure Description Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-6, which is a measure of local gingival inflammation.
Time Frame Baseline and 3 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected.

Reporting Groups
  Description
Aspirin & Docosahexaenoic Acid

Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months

Aspirin

Docosahexaenoic acid

Aspirin & Placebo

Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months

Aspirin

Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules


Measured Values
   Aspirin & Docosahexaenoic Acid   Aspirin & Placebo 
Participants Analyzed   20   19 
Gingival Crevicular Fluid Interleukin-6 
[Units: pg/mL]
Mean (Standard Error)
 0.1422  (0.5273)   -0.00226  (0.3245) 

No statistical analysis provided for Gingival Crevicular Fluid Interleukin-6



7.  Secondary:   Gingival Crevicular Fluid Interleukin-1 Beta   [ Time Frame: Baseline and 3 months ]

Measure Type Secondary
Measure Title Gingival Crevicular Fluid Interleukin-1 Beta
Measure Description Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-1 beta, which is a measure of local gingival inflammation.
Time Frame Baseline and 3 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected.

Reporting Groups
  Description
Aspirin & Docosahexaenoic Acid

Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months

Aspirin

Docosahexaenoic acid

Aspirin & Placebo

Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months

Aspirin

Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules


Measured Values
   Aspirin & Docosahexaenoic Acid   Aspirin & Placebo 
Participants Analyzed   20   19 
Gingival Crevicular Fluid Interleukin-1 Beta 
[Units: pg/mL]
Mean (Standard Error)
 0.8775  (4.7203)   21.5816  (8.0491) 

No statistical analysis provided for Gingival Crevicular Fluid Interleukin-1 Beta



8.  Secondary:   Serum High-sensitivity C-reactive Protein   [ Time Frame: Baseline and 3 months ]

Measure Type Secondary
Measure Title Serum High-sensitivity C-reactive Protein
Measure Description Serum high-sensitivity C-reactive protein is a measure of systemic inflammation.
Time Frame Baseline and 3 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Aspirin & Docosahexaenoic Acid

Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months

Aspirin

Docosahexaenoic acid

Aspirin & Placebo

Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months

Aspirin

Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules


Measured Values
   Aspirin & Docosahexaenoic Acid   Aspirin & Placebo 
Participants Analyzed   24   22 
Serum High-sensitivity C-reactive Protein 
[Units: mg/L]
Mean (Standard Error)
 -0.3695  (0.5558)   0.7114  (0.7223) 

No statistical analysis provided for Serum High-sensitivity C-reactive Protein



9.  Secondary:   Serum High-sensitivity Interleukin-6   [ Time Frame: Baseline and 3 months ]

Measure Type Secondary
Measure Title Serum High-sensitivity Interleukin-6
Measure Description Serum high-sensitivity interleukin-6 is a measure of systemic inflammation.
Time Frame Baseline and 3 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Aspirin & Docosahexaenoic Acid

Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months

Aspirin

Docosahexaenoic acid

Aspirin & Placebo

Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months

Aspirin

Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules


Measured Values
   Aspirin & Docosahexaenoic Acid   Aspirin & Placebo 
Participants Analyzed   20   21 
Serum High-sensitivity Interleukin-6 
[Units: pg/mL]
Mean (Standard Error)
 0.3295  (0.4149)   -0.0690  (0.2633) 

No statistical analysis provided for Serum High-sensitivity Interleukin-6



10.  Secondary:   Serum Soluble Vascular Cell Adhesion Molecule   [ Time Frame: Baseline and 3 months ]

Measure Type Secondary
Measure Title Serum Soluble Vascular Cell Adhesion Molecule
Measure Description Serum soluble vascular cell adhesion molecule (VCAM) is a measure of systemic inflammation.
Time Frame Baseline and 3 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Aspirin & Docosahexaenoic Acid

Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months

Aspirin

Docosahexaenoic acid

Aspirin & Placebo

Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months

Aspirin

Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules


Measured Values
   Aspirin & Docosahexaenoic Acid   Aspirin & Placebo 
Participants Analyzed   20   21 
Serum Soluble Vascular Cell Adhesion Molecule 
[Units: ng/mL]
Mean (Standard Error)
 4.8829  (24.3667)   27.9409  (19.6992) 

No statistical analysis provided for Serum Soluble Vascular Cell Adhesion Molecule



11.  Secondary:   Urine N-Terminal Telopeptides   [ Time Frame: Baseline and 3 months ]

Measure Type Secondary
Measure Title Urine N-Terminal Telopeptides
Measure Description Urine N-Terminal Telopeptides are a measure of systemic bone turnover.
Time Frame Baseline and 3 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Aspirin & Docosahexaenoic Acid

Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months

Aspirin

Docosahexaenoic acid

Aspirin & Placebo

Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months

Aspirin

Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules


Measured Values
   Aspirin & Docosahexaenoic Acid   Aspirin & Placebo 
Participants Analyzed   21   19 
Urine N-Terminal Telopeptides 
[Units: nM BCE]
Mean (Standard Error)
 103.3333  (70.5656)   61.8421  (90.5793) 

No statistical analysis provided for Urine N-Terminal Telopeptides



12.  Other Pre-specified:   Change in Red Blood Cell Membrane Docosahexaenoic Acid   [ Time Frame: Baseline and 3 months ]

Measure Type Other Pre-specified
Measure Title Change in Red Blood Cell Membrane Docosahexaenoic Acid
Measure Description Red blood cell phospholipid fatty acids were measured at baseline and 3-month follow up as a measure of adherence.
Time Frame Baseline and 3 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Aspirin & Docosahexaenoic Acid

Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months

Aspirin

Docosahexaenoic acid

Aspirin & Placebo

Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months

Aspirin

Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules


Measured Values
   Aspirin & Docosahexaenoic Acid   Aspirin & Placebo 
Participants Analyzed   21   20 
Change in Red Blood Cell Membrane Docosahexaenoic Acid 
[Units: % of total RBC FA]
Mean (Standard Error)
 2.723  (0.3882)   -0.1776  (0.1326) 

No statistical analysis provided for Change in Red Blood Cell Membrane Docosahexaenoic Acid




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Kenneth Mukamal
Organization: Beth Israel Deaconess Medical Center
phone: 617-754-1401
e-mail: kmukamal@bidmc.harvard.edu


Publications of Results:
Other Publications:

Responsible Party: Kenneth Mukamal, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01976806     History of Changes
Other Study ID Numbers: GM-023
UL1RR025758-02 ( U.S. NIH Grant/Contract )
First Submitted: October 30, 2013
First Posted: November 6, 2013
Results First Submitted: December 3, 2013
Results First Posted: March 24, 2014
Last Update Posted: December 13, 2017