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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


  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 ]

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

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

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

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

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

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

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

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

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

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

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


  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
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  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