DAP: The Effects of DHA on Periodontitis
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in the treatment of periodontitis in adults.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
-
The primary aim of this study is to investigate the effect of docosahexaenoic acid (DHA; 2 gm/day) plus low dose aspirin (ASA 81 mg/day)compared to ASA alone on periodontitis over three months. Our hypothesis is that DHA plus ASA will improve periodontitis as measured by objective periodontal exam, including decreased pocket depth (mm), gingival index (0-3), plaque index (0-3) and bleeding on probing (yes/no) compared to ASA alone.
-
Assess the effect of DHA and ASA exposure on markers of local inflammation, including gingival crevicular fluid (GCF) CRP, IL-1 beta and IL-6 three months after exposure to DHA plus ASA compared to ASA alone.
-
Evaluate potential mechanisms through changes in the periodontal microbial flora which may occur as a result of exposure to DHA and ASA compared to ASA alone. Our hypothesis is that there will be a substantial post therapy change in the microbial flora of dental plaques, favoring bacteria associated with a lower systemic inflammatory state.
-
Assess the effect of DHA and ASA exposure on markers of systemic inflammation, including serum C-Reactive Protein (CRP), interleukin-6 (IL-6) and vascular adhesion molecule (VCAM) compared to ASA. Our hypothesis is that there will be a decrease in serum CRP, IL-6 and VCAM three months after exposure to DHA plus ASA compared to ASA alone.
-
Assess the effect of DHA and ASA exposure on markers of systemic bone turnover, including urine N-terminal telopeptide (NTx) compared to ASA. Our hypothesis is that there will be a decrease in urine NTx three months after exposure to DHA plus ASA compared to ASA alone.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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 |
Drug: Aspirin
Other Names:
Drug: Docosahexaenoic acid
Other Names:
|
Active Comparator: Aspirin & Placebo Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months |
Drug: Aspirin
Other Names:
Drug: Placebo (for Docosahexaenoic acid)
Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Pocket Depth (mm) [Baseline and 3 months]
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).
Secondary Outcome Measures
- Change in Gingival Index (0-3) [Baseline and 3 months]
Gingival Index (GI) is a measure of gingival inflammation, which is assigned a score (0-3). Score Criteria: 0: No inflammation. Mild inflammation, slight change in color, slight edema, no bleeding on probing. Moderate inflammation, moderate glazing, redness, bleeding on probing. Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.
- Change in Plaque Index (0-3) [Baseline and 3 months]
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 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. 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. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
- Sites With Bleeding on Probing (Yes/no) [3 months]
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.
- Gingival Crevicular Fluid High Sensitivity C-reactive Protein [Baseline and 3 months]
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.
- Gingival Crevicular Fluid Interleukin-6 [Baseline and 3 months]
Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-6, which is a measure of local gingival inflammation.
- Gingival Crevicular Fluid Interleukin-1 Beta [Baseline and 3 months]
Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-1 beta, which is a measure of local gingival inflammation.
- Serum High-sensitivity C-reactive Protein [Baseline and 3 months]
Serum high-sensitivity C-reactive protein is a measure of systemic inflammation.
- Serum High-sensitivity Interleukin-6 [Baseline and 3 months]
Serum high-sensitivity interleukin-6 is a measure of systemic inflammation.
- Serum Soluble Vascular Cell Adhesion Molecule [Baseline and 3 months]
Serum soluble vascular cell adhesion molecule (VCAM) is a measure of systemic inflammation.
- Urine N-Terminal Telopeptides [Baseline and 3 months]
Urine N-Terminal Telopeptides are a measure of systemic bone turnover.
Other Outcome Measures
- Change in Red Blood Cell Membrane Docosahexaenoic Acid [Baseline and 3 months]
Red blood cell phospholipid fatty acids were measured at baseline and 3-month follow up as a measure of adherence.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
age >40 years
-
20 natural teeth (excluding third molars)
-
no orthodontic appliances
-
periodontitis defined as >4 teeth with pocket probing depths >5 mm
Exclusion Criteria:
-
pregnancy
-
diabetes
-
severe chronic diseases
-
gastrointestinal bleeding
-
uncontrolled chronic diseases
-
autoimmune disorders
-
conditions requiring antibiotic prophylaxis
-
warfarin
-
clopidogrel
-
antimicrobial therapy within 30 days
-
chronic use of non-steroidal anti-inflammatory drugs (other than aspirin)
-
omega-3 fatty acid use within 6 months
-
loose teeth
-
painful teeth
-
periodontal abscess
-
pocket depths >10 mm in >1 tooth
-
periodontal therapy within the past two years
-
allergy to aspirin
-
allergy to fish oil
-
allergy to corn oil
-
allergy to soybean oil
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Beth Israel Deaconess Medical Center
- National Center for Research Resources (NCRR)
- Harvard Medical School (HMS and HSDM)
Investigators
- Principal Investigator: Asghar Z Naqvi, MD, MPH, MNS, Beth Israel Deaconess Medical Center; Harvard Medical School
- Study Chair: Kenneth J Mukamal, MD, MPH, MA, Beth Israel Deaconess Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- GM-023
- UL1RR025758-02
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Aspirin & Docosahexaenoic Acid | Aspirin & Placebo |
---|---|---|
Arm/Group Description | 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 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 |
Period Title: Overall Study | ||
STARTED | 27 | 28 |
COMPLETED | 24 | 22 |
NOT COMPLETED | 3 | 6 |
Baseline Characteristics
Arm/Group Title | Aspirin & Docosahexaenoic Acid | Aspirin & Placebo | Total |
---|---|---|---|
Arm/Group Description | 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 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 of all reporting groups |
Overall Participants | 24 | 22 | 46 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
53
(8)
|
57
(8)
|
55
(8)
|
Sex: Female, Male (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) (Count of Participants) | |||
American Indian or Alaska Native |
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%
|
Black or African American |
7
29.2%
|
8
36.4%
|
15
32.6%
|
White |
12
50%
|
12
54.5%
|
24
52.2%
|
More than one race |
0
0%
|
1
4.5%
|
1
2.2%
|
Unknown or Not Reported |
1
4.2%
|
0
0%
|
1
2.2%
|
Smoking Status (participants) [Number] | |||
Current |
1
4.2%
|
1
4.5%
|
2
4.3%
|
Former |
7
29.2%
|
6
27.3%
|
13
28.3%
|
Never |
16
66.7%
|
15
68.2%
|
31
67.4%
|
BMI (kg/m2) (participants) [Number] | |||
Normal (18.5-24.9 kg/m2) |
9
37.5%
|
5
22.7%
|
14
30.4%
|
Overweight (25-30 kg/m2) |
4
16.7%
|
10
45.5%
|
14
30.4%
|
Obese (>30 kg/m2) |
11
45.8%
|
7
31.8%
|
18
39.1%
|
Hypertension (participants) [Number] | |||
Hypertension |
4
16.7%
|
6
27.3%
|
10
21.7%
|
No Hypertension |
20
83.3%
|
16
72.7%
|
36
78.3%
|
Hyperlipidemia (participants) [Number] | |||
Hyperlipidemia |
5
20.8%
|
4
18.2%
|
9
19.6%
|
No Hyperlipidemia |
19
79.2%
|
18
81.8%
|
37
80.4%
|
Outcome Measures
Title | Change in Pocket Depth (mm) |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Aspirin & Docosahexaenoic Acid | Aspirin & Placebo |
---|---|---|
Arm/Group Description | 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 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 |
Measure Participants | 24 | 22 |
Mean (Standard Error) [mm] |
-0.71
(0.07)
|
-0.54
(0.07)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Aspirin & Docosahexaenoic Acid, Aspirin & Placebo |
---|---|---|
Comments | 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. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.05 |
Comments | ||
Method | Mixed Models Analysis | |
Comments | Compound-symmetry covariance structure with age, sex, BMI, race, baseline pocket depth, baseline RBC DHA level, and intervention group variables | |
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | -0.29 | |
Confidence Interval |
() % to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.13 |
|
Estimation Comments | 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. |
Title | Change in Gingival Index (0-3) |
---|---|
Description | Gingival Index (GI) is a measure of gingival inflammation, which is assigned a score (0-3). Score Criteria: 0: No inflammation. Mild inflammation, slight change in color, slight edema, no bleeding on probing. Moderate inflammation, moderate glazing, redness, bleeding on probing. Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding. |
Time Frame | Baseline and 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Aspirin & Docosahexaenoic Acid | Aspirin & Placebo |
---|---|---|
Arm/Group Description | 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 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 |
Measure Participants | 24 | 22 |
Mean (Standard Error) [GI units] |
-0.26
(0.04)
|
-0.07
(0.04)
|
Title | Change in Plaque Index (0-3) |
---|---|
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 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. 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. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. |
Time Frame | Baseline and 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Aspirin & Docosahexaenoic Acid | Aspirin & Placebo |
---|---|---|
Arm/Group Description | 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 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 |
Measure Participants | 24 | 22 |
Mean (Standard Error) [Plaque index units] |
-0.10
(0.06)
|
0.07
(0.07)
|
Title | Sites With Bleeding on Probing (Yes/no) |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Results presented at 3 months; 3-months results also compared to baseline BOP using logistic regression as described in manuscript. |
Arm/Group Title | Aspirin & Docosahexaenoic Acid | Aspirin & Placebo |
---|---|---|
Arm/Group Description | 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 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 |
Measure Participants | 24 | 22 |
Measure Sites | 271 | 261 |
Count of Units [Sites] |
202
|
227
|
Title | Gingival Crevicular Fluid High Sensitivity C-reactive Protein |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected. |
Arm/Group Title | Aspirin & Docosahexaenoic Acid | Aspirin & Placebo |
---|---|---|
Arm/Group Description | 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 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 |
Measure Participants | 20 | 19 |
Mean (Standard Error) [ng/mL] |
-7.3715
(3.9244)
|
-3.1268
(2.0415)
|
Title | Gingival Crevicular Fluid Interleukin-6 |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected. |
Arm/Group Title | Aspirin & Docosahexaenoic Acid | Aspirin & Placebo |
---|---|---|
Arm/Group Description | 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 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 |
Measure Participants | 20 | 19 |
Mean (Standard Error) [pg/mL] |
0.1422
(0.5273)
|
-0.00226
(0.3245)
|
Title | Gingival Crevicular Fluid Interleukin-1 Beta |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected. |
Arm/Group Title | Aspirin & Docosahexaenoic Acid | Aspirin & Placebo |
---|---|---|
Arm/Group Description | 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 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 |
Measure Participants | 20 | 19 |
Mean (Standard Error) [pg/mL] |
0.8775
(4.7203)
|
21.5816
(8.0491)
|
Title | Serum High-sensitivity C-reactive Protein |
---|---|
Description | Serum high-sensitivity C-reactive protein is a measure of systemic inflammation. |
Time Frame | Baseline and 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Aspirin & Docosahexaenoic Acid | Aspirin & Placebo |
---|---|---|
Arm/Group Description | 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 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 |
Measure Participants | 24 | 22 |
Mean (Standard Error) [mg/L] |
-0.3695
(0.5558)
|
0.7114
(0.7223)
|
Title | Serum High-sensitivity Interleukin-6 |
---|---|
Description | Serum high-sensitivity interleukin-6 is a measure of systemic inflammation. |
Time Frame | Baseline and 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Aspirin & Docosahexaenoic Acid | Aspirin & Placebo |
---|---|---|
Arm/Group Description | 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 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 |
Measure Participants | 20 | 21 |
Mean (Standard Error) [pg/mL] |
0.3295
(0.4149)
|
-0.0690
(0.2633)
|
Title | Serum Soluble Vascular Cell Adhesion Molecule |
---|---|
Description | Serum soluble vascular cell adhesion molecule (VCAM) is a measure of systemic inflammation. |
Time Frame | Baseline and 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Aspirin & Docosahexaenoic Acid | Aspirin & Placebo |
---|---|---|
Arm/Group Description | 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 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 |
Measure Participants | 20 | 21 |
Mean (Standard Error) [ng/mL] |
4.8829
(24.3667)
|
27.9409
(19.6992)
|
Title | Urine N-Terminal Telopeptides |
---|---|
Description | Urine N-Terminal Telopeptides are a measure of systemic bone turnover. |
Time Frame | Baseline and 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Aspirin & Docosahexaenoic Acid | Aspirin & Placebo |
---|---|---|
Arm/Group Description | 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 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 |
Measure Participants | 21 | 19 |
Mean (Standard Error) [nM BCE] |
103.3333
(70.5656)
|
61.8421
(90.5793)
|
Title | Change in Red Blood Cell Membrane Docosahexaenoic Acid |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Aspirin & Docosahexaenoic Acid | Aspirin & Placebo |
---|---|---|
Arm/Group Description | 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 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 |
Measure Participants | 21 | 20 |
Mean (Standard Error) [% of total RBC FA] |
2.723
(0.3882)
|
-0.1776
(0.1326)
|
Adverse Events
Time Frame | 3 months | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day) | Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day) | ||
Arm/Group Description | ||||
All Cause Mortality |
||||
DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day) | Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day) | Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/27 (0%) | 0/28 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day) | Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 7/27 (25.9%) | 8/28 (28.6%) | ||
Blood and lymphatic system disorders | ||||
Gingival bleeding while flossing | 0/27 (0%) | 0 | 1/28 (3.6%) | 1 |
Cardiac disorders | ||||
Intermittent palpitations | 1/27 (3.7%) | 0/28 (0%) | ||
Gastrointestinal disorders | ||||
Dyspepsia | 2/27 (7.4%) | 2 | 2/28 (7.1%) | 2 |
Flatulence | 3/27 (11.1%) | 3 | 1/28 (3.6%) | 1 |
Diarrhea | 1/27 (3.7%) | 1/28 (3.6%) | ||
Melena | 0/27 (0%) | 1/28 (3.6%) | ||
Nausea | 0/27 (0%) | 1/28 (3.6%) | ||
GERD | 0/27 (0%) | 1/28 (3.6%) | ||
General disorders | ||||
Fatigue | 2/27 (7.4%) | 1/28 (3.6%) | ||
Headache | 2/27 (7.4%) | 0/28 (0%) | ||
Chipped tooth | 1/27 (3.7%) | 0/28 (0%) | ||
Diaphoresis | 1/27 (3.7%) | 0/28 (0%) | ||
Infections and infestations | ||||
Upper respiratory infection | 0/27 (0%) | 1/28 (3.6%) | ||
Cavity | 0/27 (0%) | 1/28 (3.6%) | ||
Psychiatric disorders | ||||
Verbally abusive toward staff | 0/27 (0%) | 1/28 (3.6%) |
Limitations/Caveats
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 |
kmukamal@bidmc.harvard.edu |
- GM-023
- UL1RR025758-02