Trial Outcomes & Findings for Effect of Omega-3 Fatty Acids Supplementation on Hypertriglyceridemia in Pediatric Patients With Obesity. (NCT NCT03216057)
NCT ID: NCT03216057
Last Updated: 2025-03-18
Results Overview
Percentage change in serum triglyceride levels from baseline to week 12 of study treatment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
168 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-03-18
Participant Flow
The subjects were enrolled from Obesity Clinic and Department of Pediatric Allergy and Clinical Immunology of the Children's Hospital of Mexico.
First of all, the researcher has enrolled 168 subjects, who were assessed for eligibility, but 38 subjects have done screen failure because they have not met all the inclusion criteria, therefore only 130 subjects, who have started the study, were randomized.
Participant milestones
| Measure |
Omega-3
Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 grams of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega Rx Dr.Sears Zone labs Inc.
Omega-3 fatty acid 3 grams per day: Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 gr of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega RX Dr.Sears Zone labs Inc.
|
Placebo
Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
Placebo: Placebo Comparator: Placebo Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
65
|
|
Overall Study
COMPLETED
|
63
|
63
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Omega-3
Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 grams of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega Rx Dr.Sears Zone labs Inc.
Omega-3 fatty acid 3 grams per day: Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 gr of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega RX Dr.Sears Zone labs Inc.
|
Placebo
Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
Placebo: Placebo Comparator: Placebo Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Effect of Omega-3 Fatty Acids Supplementation on Hypertriglyceridemia in Pediatric Patients With Obesity.
Baseline characteristics by cohort
| Measure |
Omega-3
n=65 Participants
Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 grams of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega Rx Dr.Sears Zone labs Inc.
Omega-3 fatty acid 3 grams per day: Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 gr of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega RX Dr.Sears Zone labs Inc.
|
Placebo
n=65 Participants
Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
Placebo: Placebo Comparator: Placebo Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
|
Total
n=130 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
12.1 years
STANDARD_DEVIATION 1.6 • n=99 Participants
|
12.5 years
STANDARD_DEVIATION 1.5 • n=107 Participants
|
12.3 years
STANDARD_DEVIATION 1.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Weight
|
70.4 Kilograms
STANDARD_DEVIATION 16.2 • n=99 Participants
|
68.4 Kilograms
STANDARD_DEVIATION 14.2 • n=107 Participants
|
69.4 Kilograms
STANDARD_DEVIATION 15.2 • n=206 Participants
|
|
Height
|
155.0 centimeters
STANDARD_DEVIATION 10.7 • n=99 Participants
|
154.5 centimeters
STANDARD_DEVIATION 10.7 • n=107 Participants
|
154.8 centimeters
STANDARD_DEVIATION 10.7 • n=206 Participants
|
|
Body Mass Index
|
28.9 Kg/m^2
STANDARD_DEVIATION 3.8 • n=99 Participants
|
28.2 Kg/m^2
STANDARD_DEVIATION 3.0 • n=107 Participants
|
28.6 Kg/m^2
STANDARD_DEVIATION 3.4 • n=206 Participants
|
|
Abdominal circumference
|
95.5 centimeters
STANDARD_DEVIATION 10.6 • n=99 Participants
|
93.5 centimeters
STANDARD_DEVIATION 8.4 • n=107 Participants
|
94.5 centimeters
STANDARD_DEVIATION 9.6 • n=206 Participants
|
|
Hip circumference
|
91.6 centimeters
STANDARD_DEVIATION 10.0 • n=99 Participants
|
90.1 centimeters
STANDARD_DEVIATION 7.5 • n=107 Participants
|
90.8 centimeters
STANDARD_DEVIATION 8.8 • n=206 Participants
|
|
Waist circumference
|
99.8 centimeters
STANDARD_DEVIATION 11.05 • n=99 Participants
|
98.9 centimeters
STANDARD_DEVIATION 8.6 • n=107 Participants
|
99.4 centimeters
STANDARD_DEVIATION 9.8 • n=206 Participants
|
|
Triglycerides
|
222.1 mg/dl
STANDARD_DEVIATION 62.3 • n=99 Participants
|
222.6 mg/dl
STANDARD_DEVIATION 75.9 • n=107 Participants
|
222.4 mg/dl
STANDARD_DEVIATION 69.2 • n=206 Participants
|
|
Cholesterol
|
165.0 mg/dl
STANDARD_DEVIATION 30.2 • n=99 Participants
|
157.9 mg/dl
STANDARD_DEVIATION 38.3 • n=107 Participants
|
161.4 mg/dl
STANDARD_DEVIATION 34.5 • n=206 Participants
|
|
Glucose
|
86.9 mg/dl
STANDARD_DEVIATION 8.7 • n=99 Participants
|
85.3 mg/dl
STANDARD_DEVIATION 13.1 • n=107 Participants
|
86.1 mg/dl
STANDARD_DEVIATION 11.1 • n=206 Participants
|
|
HDL-C
|
34.6 mg/dl
STANDARD_DEVIATION 9.8 • n=99 Participants
|
32.6 mg/dl
STANDARD_DEVIATION 6.7 • n=107 Participants
|
33.6 mg/dl
STANDARD_DEVIATION 8.4 • n=206 Participants
|
|
Uric acid
|
6.0 mg/dl
STANDARD_DEVIATION 1.3 • n=99 Participants
|
5.8 mg/dl
STANDARD_DEVIATION 1.0 • n=107 Participants
|
5.9 mg/dl
STANDARD_DEVIATION 1.1 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Intention to treat population (All subjects who received at least one dose of intervention were assessed in statistical analysis)
Percentage change in serum triglyceride levels from baseline to week 12 of study treatment
Outcome measures
| Measure |
Omega-3
n=65 Participants
Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 grams of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega Rx Dr.Sears Zone labs Inc.
Omega-3 fatty acid 3 grams per day: Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 gr of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega RX Dr.Sears Zone labs Inc.
|
Placebo
n=65 Participants
Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
Placebo: Placebo Comparator: Placebo Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
|
|---|---|---|
|
Percentage Change in Serum Triglyceride Levels From Baseline to Week 12 of Study Treatment
|
-39.1 Percent change (%)
Standard Deviation 24.7
|
-14.6 Percent change (%)
Standard Deviation 21.8
|
PRIMARY outcome
Timeframe: 12 weeksMilligram Change in Serum Triglyceride Levels From Baseline to Week 12 of Study Treatment
Outcome measures
| Measure |
Omega-3
n=65 Participants
Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 grams of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega Rx Dr.Sears Zone labs Inc.
Omega-3 fatty acid 3 grams per day: Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 gr of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega RX Dr.Sears Zone labs Inc.
|
Placebo
n=65 Participants
Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
Placebo: Placebo Comparator: Placebo Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
|
|---|---|---|
|
Milligram Change in Serum Triglyceride Levels From Baseline to Week 12 of Study Treatment
|
127.7 mg/dl
Standard Deviation 45.5
|
187.6 mg/dl
Standard Deviation 80.4
|
SECONDARY outcome
Timeframe: 12 weeksPercentage Change in Serum Cholesterol Levels From Baseline to Week 12 of Study Treatment
Outcome measures
| Measure |
Omega-3
n=65 Participants
Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 grams of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega Rx Dr.Sears Zone labs Inc.
Omega-3 fatty acid 3 grams per day: Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 gr of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega RX Dr.Sears Zone labs Inc.
|
Placebo
n=65 Participants
Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
Placebo: Placebo Comparator: Placebo Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
|
|---|---|---|
|
Percentage Change in Serum Cholesterol Levels From Baseline to Week 12 of Study Treatment
|
-2.9 Percent change (%)
Standard Deviation 19.5
|
6.1 Percent change (%)
Standard Deviation 20.6
|
SECONDARY outcome
Timeframe: 12 weeksMilligram Change in Serum Cholesterol Levels From Baseline to Week 12 of Study Treatment
Outcome measures
| Measure |
Omega-3
n=65 Participants
Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 grams of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega Rx Dr.Sears Zone labs Inc.
Omega-3 fatty acid 3 grams per day: Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 gr of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega RX Dr.Sears Zone labs Inc.
|
Placebo
n=65 Participants
Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
Placebo: Placebo Comparator: Placebo Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
|
|---|---|---|
|
Milligram Change in Serum Cholesterol Levels From Baseline to Week 12 of Study Treatment
|
157.4 mg/dl
Standard Deviation 31.4
|
162.4 mg/dl
Standard Deviation 30.7
|
SECONDARY outcome
Timeframe: 12 weeksPercentage Change in Serum HDL-C Levels From Baseline to Week 12 of Study Treatment
Outcome measures
| Measure |
Omega-3
n=65 Participants
Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 grams of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega Rx Dr.Sears Zone labs Inc.
Omega-3 fatty acid 3 grams per day: Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 gr of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega RX Dr.Sears Zone labs Inc.
|
Placebo
n=65 Participants
Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
Placebo: Placebo Comparator: Placebo Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
|
|---|---|---|
|
Percentage Change in Serum HDL-C Levels From Baseline to Week 12 of Study Treatment
|
3.8 Percent change (%)
Standard Deviation 22.3
|
16.2 Percent change (%)
Standard Deviation 27.5
|
SECONDARY outcome
Timeframe: 12 weeksMilligram Change in Serum HDL-C Levels From Baseline to Week 12 of Study Treatment
Outcome measures
| Measure |
Omega-3
n=65 Participants
Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 grams of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega Rx Dr.Sears Zone labs Inc.
Omega-3 fatty acid 3 grams per day: Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 gr of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega RX Dr.Sears Zone labs Inc.
|
Placebo
n=65 Participants
Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
Placebo: Placebo Comparator: Placebo Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
|
|---|---|---|
|
Milligram Change in Serum HDL-C Levels From Baseline to Week 12 of Study Treatment
|
34.4 mg/dl
Standard Deviation 5.2
|
36.7 mg/dl
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: 12 weeksPercentage Change in Serum Glucose Levels From Baseline to Week 12 of Study Treatment
Outcome measures
| Measure |
Omega-3
n=65 Participants
Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 grams of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega Rx Dr.Sears Zone labs Inc.
Omega-3 fatty acid 3 grams per day: Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 gr of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega RX Dr.Sears Zone labs Inc.
|
Placebo
n=65 Participants
Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
Placebo: Placebo Comparator: Placebo Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
|
|---|---|---|
|
Percentage Change in Serum Glucose Levels From Baseline to Week 12 of Study Treatment
|
-0.4 Percent change (%)
Standard Deviation 10.1
|
0.7 Percent change (%)
Standard Deviation 17.7
|
SECONDARY outcome
Timeframe: 12 weeksMilligram Change in Glucose Levels From Baseline to Week 12 of Study Treatment
Outcome measures
| Measure |
Omega-3
n=65 Participants
Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 grams of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega Rx Dr.Sears Zone labs Inc.
Omega-3 fatty acid 3 grams per day: Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 gr of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega RX Dr.Sears Zone labs Inc.
|
Placebo
n=65 Participants
Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
Placebo: Placebo Comparator: Placebo Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
|
|---|---|---|
|
Milligram Change in Glucose Levels From Baseline to Week 12 of Study Treatment
|
86.1 mg/dl
Standard Deviation 8.6
|
84.1 mg/dl
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: 12 weeksPercentage Change in Serum Uric Acid Levels From Baseline to Week 12 of Study Treatment
Outcome measures
| Measure |
Omega-3
n=65 Participants
Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 grams of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega Rx Dr.Sears Zone labs Inc.
Omega-3 fatty acid 3 grams per day: Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 gr of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega RX Dr.Sears Zone labs Inc.
|
Placebo
n=65 Participants
Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
Placebo: Placebo Comparator: Placebo Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
|
|---|---|---|
|
Percentage Change in Serum Uric Acid Levels From Baseline to Week 12 of Study Treatment
|
-1.9 Percent change (%)
Standard Deviation 26.0
|
-15.3 Percent change (%)
Standard Deviation 16.0
|
SECONDARY outcome
Timeframe: 12 weeksMilligram Change in Serum Uric Acid Levels From Baseline to Week 12 of Study Treatment
Outcome measures
| Measure |
Omega-3
n=65 Participants
Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 grams of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega Rx Dr.Sears Zone labs Inc.
Omega-3 fatty acid 3 grams per day: Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 gr of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega RX Dr.Sears Zone labs Inc.
|
Placebo
n=65 Participants
Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
Placebo: Placebo Comparator: Placebo Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
|
|---|---|---|
|
Milligram Change in Serum Uric Acid Levels From Baseline to Week 12 of Study Treatment
|
5.7 mg/dl
Standard Deviation 1.4
|
4.8 mg/dl
Standard Deviation 0.8
|
Adverse Events
Omega-3
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omega-3
n=65 participants at risk
Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 grams of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega Rx Dr.Sears Zone labs Inc.
Omega-3 fatty acid 3 grams per day: Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 gr of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega RX Dr.Sears Zone labs Inc.
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Placebo
n=65 participants at risk
Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
Placebo: Placebo Comparator: Placebo. Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
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|---|---|---|
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Gastrointestinal disorders
Abdominal pain
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1.5%
1/65 • 12 weeks
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3.1%
2/65 • 12 weeks
|
|
Gastrointestinal disorders
Fish taste belch
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27.7%
18/65 • 12 weeks
|
0.00%
0/65 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
7.7%
5/65 • 12 weeks
|
3.1%
2/65 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
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1.5%
1/65 • 12 weeks
|
0.00%
0/65 • 12 weeks
|
|
Gastrointestinal disorders
Flatulence
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3.1%
2/65 • 12 weeks
|
0.00%
0/65 • 12 weeks
|
Additional Information
Blanca Estela Del Rio Navarro
Hospital Infantil de Mexico Federico Gomez
Phone: +525552289917
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place