HypertriglyceridemiaNCT03216057
Effect of Omega-3 Fatty Acids Supplementation on Hypertriglyceridemia in Pediatric Patients With Obesity.
A study testing Omega-3 fatty acid 3 grams per day in people with Hypertriglyceridemia and Pediatric Obesity, run by Hospital Infantil de Mexico Federico Gomez.
Trial summary
The primary objective was to evaluate the safety and efficacy the 3 grams per day of omega-3 in adolescents with obesity and hypertriglyceridemia ( ≥ 150 mg/dl and ≤ 1000 mg/dl) for 12 weeks, compared with placebo. Half of subjects received 3 grams of omega 3, while the other half received placebo. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Hypertriglyceridemia, Pediatric Obesity
- What is being tested?
- Omega-3 fatty acid 3 grams per day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2008to 22 Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 10-16 years old
- Informed consent from a parent or legal guardian of minors or adult subject
- Written assent from the adolescent to participate in the study
- Obese patients (Body Mass Index ≥95th percentile according to the National Center for Health Statistics, Center for Disease Control and Prevention [CDC].
- Fasting Serum triglycerides ≥150 mg/dL and ≤1000 mg/dL.
- Cooperation to ingest capsules (omega-3 or placebo) and taking laboratories
Who cannot join
- The subjects must not had received pharmacology treatment for hypertriglyceridemia six months before and at the time of enrollment.
- Treatment with medications that affect triglyceride levels, including oral hypoglycemic agents or insulin.
- Pregnancy or positive urine pregnancy test for those females who have begun menstruating.
- Known Bleeding Disorder or Coagulopathy or treatment with anticoagulant medications or low platelet counts, abnormal PT, or PTT.
- Subjects with mental delayed.
- Neurological disorder.
Show all 22Show fewer
- Subjects with Cardiopathy
- Subjects with gastroesophageal reflux
- Endocrinopathies such as thyroid disorder, Hypothalamic disorder and Type 1 or 2 diabetes or fasting glucose that is >=126 mg/dl.
- Subjects with liver disease
- Familial hypertriglyceridemia.
- Familial hypercholesterolemia
- Polycystic ovary syndrome
- Use of contraceptives by any way of administration 6 months before and at the time of enrollment.
- Use of vitamins 6 months before and at the time of enrollment.
- Allergy to fish oil.
- Allergy to soybean oil.
- Elimination criteria:
- Subject or parents´ subject either decision to discontinue of the study at any time without prejudice to further treatment.
- Serious adverse event.
- Safety reason as judged by the investigator.
- Pregnancy.
About this study
Official title: Effect of Omega-3 Fatty Acids Supplementation on Hypertriglyceridemia in Pediatric Patients With Obesity. A Randomized, Double Blind, Placebo-controlled Clinical Trial.
The primary objective was to evaluate the safety and efficacy the 3 grams per day of omega-3 in adolescents with obesity and hypertriglyceridemia ( ≥ 150 mg/dl and ≤ 1000 mg/dl) for 12 weeks, compared with placebo. Half of subjects received 3 grams of omega 3, while the other half received placebo.
Read the detailed description
First of all, the omega-3 free fatty acids have an important effect for lowering triglycerides through three potential mechanisms such as:
Inhibition of triacylglycerol synthesis as direct inhibition of diacyl glycerol acetyl transferase and phosphatidic acid phosphohydrolase results in lowering triacylglycerol production.
Simulation of fatty acid oxidation through activation of peroxisome proliferation activated receptor stimulates hepatic mitochondrial and peroxisomal beta oxidation of fatty acids. Decreased availability of fatty acids for triacylglycerol synthesis results in lowering plasma triacylglycerol levels Lipoprotein Lipase mediated clearance. One of the first randomized double blind placebo controlled clinical trials was managed by Harris in 1997 in adult subjects with an average age of 46 ± 11 years and severe hypertriglyceridemia (500-2000 mg / dl) 20 subjects received placebo and 22 subjects 4 grams of omega-3. The mean percent change from baseline in the omega-3 group was -45 ± 23% and in the placebo group was -16 ± 35% (p <0.0001).
Also, more clinical trials have recently been conducted with similar results such as the most recent randomized, double-blind, placebo-controlled clinical trial that was conducted by Ta-Chen Su in Taiwan in adults with hypertriglyceridemia (200-1000 mg / dl). The first group received 4 grams of omega-3 (n = 84), the second group received 2 grams of omega-3 (n = 82) and the third group received placebo (n = 87). The mean percent change from baseline in the 4 grams of omega-3 group was -32.1%, in the 2 grams group of omega-3 was -29.7% and in the placebo group was -5.4% (p <0.0001) What is more, the strongest scientific evidence in favor of supplementation of omega-3 acids fatty was determined by two meta-analysis, the first study was published by Harris in 1997 that included 72 placebo-controlled clinical trials, the study showed a reduction of 25-30% triglycerides levels with doses of 3-4 g omega-3 compared with placebo in subjects with triglycerides levels ≥500mg / dl. The second meta-analysis by Balk that included 17 clinical trials (7,803 patients) with different doses of omega-3 (0.8-5.4 g). The net reduction in triglycerides levels was -27 mg / dl (IC95% 22-30), p <0.0001 In addition, the American Heart Association based on the meta-analysis by Harris currently recommends the administration of 2 to 4 grams of omega-3 per day for the treatment of severe hypertriglyceridemia (≥500mg / dl) in adult patients.
Secondly, the Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) currently recommends that if hypertriglyceridemia is not able to reduce with statins or fibrates the physician will prescribe 2-4 grams of omega-3 fatty acids to reduce triglyceride levels in adult patients.
Finally, the Food Drug Administration (FDA) in 2004 authorized the administration of 2 to 4 grams of omega-3 per day for the treatment of severe hypertriglyceridemia (≥500mg / dl) in adult patients.
There is enough evidence that medical literature supports the use of omega-3 in adult patients for treatment of hypertriglyceridemia even the American Heart Association has made the recommendation in its Scientific Statement but unfortunately in children the information about the use of omega-3 for hypertriglyceridemia is insufficient to make clinical decisions.
There are no specific recommendations and dosages of omega-3 in children and adolescents for the treatment of hypertriglyceridemia.
A randomized, double-blind placebo controlled clinical trials are necessary to assess the efficacy and safety of omega-3 fatty acids for the treatment of hypertriglyceridemia in children and adolescents.
Main objective:
Assessing the efficacy and safety of supplementation of 3 grams of omega-3 fatty acids for 12 weeks on serum triglycerides in adolescents with obesity and hypertriglyceridemia compared to a control group that received placebo.
Secondary objective:
Assessing the efficacy and safety of supplementation of 3 grams of omega-3 fatty acids for 12 weeks on serum cholesterol, HDL-C, glucose and uric acid in adolescents with obesity and hypertriglyceridemia compared to a control group that received placebo.
Study plan detailing the procedures.
Visit 1 Enrollment:
The subject was picked up by the Allergy Department and Obesity Clinic. Informed consent and informed assent. Demography (date of birth, gender) and evaluation of Inclusion/Exclusion criteria Medical. Surgical history physical examination and anthropometry (weight, height, body mass index, abdominal perimeter, waist and hip). Pulse and blood pressure. Pregnancy test. Fasting venous blood samples of 12 hours for the measurement of triglycerides and metabolic profile. Food recommendation was indicated by the Pediatric Clinical Nutrition Service. Physical activity was indicated with a 30-minute walk per day for seven days per week by the Pediatric Clinical Nutrition service.
Visit 2 Randomization:
Triglyceride levels were reviewed, in case of report ≥150 mg / dl and ≤ 1000 mg/dl the subjects were randomized.
The type of randomization used was blocked randomisation, number of subjects per block were 10 and number of blocks were 13. (130 subjects were randomized).
Allocation of omega-3 or placebo capsules for all randomized subjects and beginning of the week 0 of treatment.
Visit 3 Treatment week 4 Allocation of omega-3 or placebo capsules. Checking of adverse effects. Accounting of capsules. Supervision of compliance diary of omega-3 or placebo capsules. Supervision of compliance diary food recommendation. Supervision of compliance physical activity
Visit 4 Treatment week 8 Allocation of omega-3 or placebo capsules. Checking of adverse effects. Accounting of capsules. Supervision of compliance diary of omega-3 or placebo capsules. Supervision of compliance diary food recommendation. Supervision of compliance physical activity.
Visit 5 Treatment week 12 Checking of adverse effects. Accounting of capsules. Supervision of compliance diary of omega-3 or placebo capsules. Supervision of compliance diary food recommendation. Supervision of compliance physical activity.
Follow-up telephone call week 16. A follow-up telephone was performed 4 weeks after the visit 5. At the follow-up telephone call, the investigator checked adverse events.
- Conditions
- Hypertriglyceridemia, Pediatric Obesity
- Being tested
- Omega-3 fatty acid 3 grams per day, Placebo
- Keywords
- hypertriglyceridemia, pediatric obesity, omega 3
- Medical subject headings
- Hypertriglyceridemia, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acid 3 grams per dayDietary supplement
Also called 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 gr of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega RX Dr.Sears Zone labs Inc.
PlaceboDietary supplement
Also called Soybean oil
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.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 fatty acid 3 grams per day | Experimental | 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. Receives: Dietary Supplement: Omega-3 fatty acid 3 grams per day |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Serum Triglyceride Levels From Baseline to Week 12 of Study Treatment
Percentage change in serum triglyceride levels from baseline to week 12 of study treatment
Measured: 12 weeks
Milligram Change in Serum Triglyceride Levels From Baseline to Week 12 of Study Treatment
Milligram Change in Serum Triglyceride Levels From Baseline to Week 12 of Study Treatment
Measured: 12 weeks
Secondary outcomes (8)
Percentage Change in Serum Cholesterol Levels From Baseline to Week 12 of Study Treatment
Percentage Change in Serum Cholesterol Levels From Baseline to Week 12 of Study Treatment
Measured: 12 weeks
Milligram Change in Serum Cholesterol Levels From Baseline to Week 12 of Study Treatment
Milligram Change in Serum Cholesterol Levels From Baseline to Week 12 of Study Treatment
Measured: 12 weeks
Percentage Change in Serum HDL-C Levels From Baseline to Week 12 of Study Treatment
Percentage Change in Serum HDL-C Levels From Baseline to Week 12 of Study Treatment
Measured: 12 weeks
Milligram Change in Serum HDL-C Levels From Baseline to Week 12 of Study Treatment
Milligram Change in Serum HDL-C Levels From Baseline to Week 12 of Study Treatment
Measured: 12 weeks
Percentage Change in Serum Glucose Levels From Baseline to Week 12 of Study Treatment
Percentage Change in Serum Glucose Levels From Baseline to Week 12 of Study Treatment
Measured: 12 weeks
Milligram Change in Glucose Levels From Baseline to Week 12 of Study Treatment
Milligram Change in Glucose Levels From Baseline to Week 12 of Study Treatment
Measured: 12 weeks
Percentage Change in Serum Uric Acid Levels From Baseline to Week 12 of Study Treatment
Percentage Change in Serum Uric Acid Levels From Baseline to Week 12 of Study Treatment
Measured: 12 weeks
Milligram Change in Serum Uric Acid Levels From Baseline to Week 12 of Study Treatment
Milligram Change in Serum Uric Acid Levels From Baseline to Week 12 of Study Treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start20 May 2008
- Primary completion22 Nov 2016
- Study completion22 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Infantil de Mexico Federico Gomez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blanca Estela Del Rio Navarro, Hospital Infantil de Mexico Federico Gomez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216057
- Sponsor's protocol ID
- HIM/2008/006
- Status last verified
- Mar 2025
- First submitted
- 10 Jul 2017
- Last updated
- 18 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harris WS, Ginsberg HN, Arunakul N, Shachter NS, Windsor SL, Adams M, Berglund L, Osmundsen K. Safety and efficacy of Omacor in severe hypertriglyceridemia. J Cardiovasc Risk. 1997 Oct-Dec;4(5-6):385-91.
PubMed 9865671Harris WS. n-3 fatty acids and serum lipoproteins: human studies. Am J Clin Nutr. 1997 May;65(5 Suppl):1645S-1654S. doi: 10.1093/ajcn/65.5.1645S.
PubMed 9129504Jacobson TA. Role of n-3 fatty acids in the treatment of hypertriglyceridemia and cardiovascular disease. Am J Clin Nutr. 2008 Jun;87(6):1981S-90S. doi: 10.1093/ajcn/87.6.1981S.
PubMed 18541599Miller M, Stone NJ, Ballantyne C, Bittner V, Criqui MH, Ginsberg HN, Goldberg AC, Howard WJ, Jacobson MS, Kris-Etherton PM, Lennie TA, Levi M, Mazzone T, Pennathur S; American Heart Association Clinical Lipidology, Thrombosis, and Prevention Committee of the Council on Nutrition, Physical Activity, and Metabolism; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2011 May 24;123(20):2292-333. doi: 10.1161/CIR.0b013e3182160726. Epub 2011 Apr 18. No abstract available.
PubMed 21502576Su TC, Hwang JJ, Huang KC, Chiang FT, Chien KL, Wang KY, Charng MJ, Tsai WC, Lin LY, Vige R, Olivar JE, Tseng CD. A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Ethyl-Ester Omega-3 Fatty Acid in Taiwanese Hypertriglyceridemic Patients. J Atheroscler Thromb. 2017 Mar 1;24(3):275-289. doi: 10.5551/jat.34231. Epub 2016 Sep 6.
PubMed 27600795Kastelein JJ, Maki KC, Susekov A, Ezhov M, Nordestgaard BG, Machielse BN, Kling D, Davidson MH. Omega-3 free fatty acids for the treatment of severe hypertriglyceridemia: the EpanoVa fOr Lowering Very high triglyceridEs (EVOLVE) trial. J Clin Lipidol. 2014 Jan-Feb;8(1):94-106. doi: 10.1016/j.jacl.2013.10.003. Epub 2013 Oct 14.
PubMed 24528690Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Z, Riccardi G, Taskinen MR, Tokgozoglu L, Verschuren WM, Vlachopoulos C, Wood DA, Zamorano JL. [2016 ESC/EAS Guidelines for the Management of Dyslipidaemias]. Kardiol Pol. 2016;74(11):1234-1318. doi: 10.5603/KP.2016.0157. No abstract available. Polish.
PubMed 27910077Balk EM, Lichtenstein AH, Chung M, Kupelnick B, Chew P, Lau J. Effects of omega-3 fatty acids on serum markers of cardiovascular disease risk: a systematic review. Atherosclerosis. 2006 Nov;189(1):19-30. doi: 10.1016/j.atherosclerosis.2006.02.012. Epub 2006 Mar 10.
PubMed 16530201Bays HE, Tighe AP, Sadovsky R, Davidson MH. Prescription omega-3 fatty acids and their lipid effects: physiologic mechanisms of action and clinical implications. Expert Rev Cardiovasc Ther. 2008 Mar;6(3):391-409. doi: 10.1586/14779072.6.3.391.
PubMed 18327998Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2889-934. doi: 10.1016/j.jacc.2013.11.002. Epub 2013 Nov 12. No abstract available.
PubMed 24239923
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Omega-3 Fatty Acids Supplementation on Hypertriglyceridemia in Pediatric Patients With Obesity. A Randomized, Double Blind, Placebo-controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03216057
- Acronym / sponsor ID
- HIM/2008/006
- Conditions
- Hypertriglyceridemia, Pediatric Obesity
- Keywords
- hypertriglyceridemia, pediatric obesity, omega 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Hospital Infantil de Mexico Federico GomezUniversity, hospital or other
- Study start
- 20 May 2008 (actual)
- Primary completion
- 22 Nov 2016 (actual)
- Study completion
- 22 Nov 2016 (actual)
- First posted
- 13 Jul 2017 (actual)
- Results
- Posted 18 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective was to evaluate the safety and efficacy the 3 grams per day of omega-3 in adolescents with obesity and hypertriglyceridemia ( ≥ 150 mg/dl and ≤ 1000 mg/dl) for 12 weeks, compared with placebo. Half of subjects received 3 grams of omega 3, while the other half received placebo.
Detailed description
First of all, the omega-3 free fatty acids have an important effect for lowering triglycerides through three potential mechanisms such as:
Inhibition of triacylglycerol synthesis as direct inhibition of diacyl glycerol acetyl transferase and phosphatidic acid phosphohydrolase results in lowering triacylglycerol production.
Simulation of fatty acid oxidation through activation of peroxisome proliferation activated receptor stimulates hepatic mitochondrial and peroxisomal beta oxidation of fatty acids. Decreased availability of fatty acids for triacylglycerol synthesis results in lowering plasma triacylglycerol levels Lipoprotein Lipase mediated clearance. One of the first randomized double blind placebo controlled clinical trials was managed by Harris in 1997 in adult subjects with an average age of 46 ± 11 years and severe hypertriglyceridemia (500-2000 mg / dl) 20 subjects received placebo and 22 subjects 4 grams of omega-3. The mean percent change from baseline in the omega-3 group was -45 ± 23% and in the placebo group was -16 ± 35% (p <0.0001).
Also, more clinical trials have recently been conducted with similar results such as the most recent randomized, double-blind, placebo-controlled clinical trial that was conducted by Ta-Chen Su in Taiwan in adults with hypertriglyceridemia (200-1000 mg / dl). The first group received 4 grams of omega-3 (n = 84), the second group received 2 grams of omega-3 (n = 82) and the third group received placebo (n = 87). The mean percent change from baseline in the 4 grams of omega-3 group was -32.1%, in the 2 grams group of omega-3 was -29.7% and in the placebo group was -5.4% (p <0.0001) What is more, the strongest scientific evidence in favor of supplementation of omega-3 acids fatty was determined by two meta-analysis, the first study was published by Harris in 1997 that included 72 placebo-controlled clinical trials, the study showed a reduction of 25-30% triglycerides levels with doses of 3-4 g omega-3 compared with placebo in subjects with triglycerides levels ≥500mg / dl. The second meta-analysis by Balk that included 17 clinical trials (7,803 patients) with different doses of omega-3 (0.8-5.4 g). The net reduction in triglycerides levels was -27 mg / dl (IC95% 22-30), p <0.0001 In addition, the American Heart Association based on the meta-analysis by Harris currently recommends the administration of 2 to 4 grams of omega-3 per day for the treatment of severe hypertriglyceridemia (≥500mg / dl) in adult patients.
Secondly, the Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) currently recommends that if hypertriglyceridemia is not able to reduce with statins or fibrates the physician will prescribe 2-4 grams of omega-3 fatty acids to reduce triglyceride levels in adult patients.
Finally, the Food Drug Administration (FDA) in 2004 authorized the administration of 2 to 4 grams of omega-3 per day for the treatment of severe hypertriglyceridemia (≥500mg / dl) in adult patients.
There is enough evidence that medical literature supports the use of omega-3 in adult patients for treatment of hypertriglyceridemia even the American Heart Association has made the recommendation in its Scientific Statement but unfortunately in children the information about the use of omega-3 for hypertriglyceridemia is insufficient to make clinical decisions.
There are no specific recommendations and dosages of omega-3 in children and adolescents for the treatment of hypertriglyceridemia.
A randomized, double-blind placebo controlled clinical trials are necessary to assess the efficacy and safety of omega-3 fatty acids for the treatment of hypertriglyceridemia in children and adolescents.
Main objective:
Assessing the efficacy and safety of supplementation of 3 grams of omega-3 fatty acids for 12 weeks on serum triglycerides in adolescents with obesity and hypertriglyceridemia compared to a control group that received placebo.
Secondary objective:
Assessing the efficacy and safety of supplementation of 3 grams of omega-3 fatty acids for 12 weeks on serum cholesterol, HDL-C, glucose and uric acid in adolescents with obesity and hypertriglyceridemia compared to a control group that received placebo.
Study plan detailing the procedures.
Visit 1 Enrollment:
The subject was picked up by the Allergy Department and Obesity Clinic. Informed consent and informed assent. Demography (date of birth, gender) and evaluation of Inclusion/Exclusion criteria Medical. Surgical history physical examination and anthropometry (weight, height, body mass index, abdominal perimeter, waist and hip). Pulse and blood pressure. Pregnancy test. Fasting venous blood samples of 12 hours for the measurement of triglycerides and metabolic profile. Food recommendation was indicated by the Pediatric Clinical Nutrition Service. Physical activity was indicated with a 30-minute walk per day for seven days per week by the Pediatric Clinical Nutrition service.
Visit 2 Randomization:
Triglyceride levels were reviewed, in case of report ≥150 mg / dl and ≤ 1000 mg/dl the subjects were randomized.
The type of randomization used was blocked randomisation, number of subjects per block were 10 and number of blocks were 13. (130 subjects were randomized).
Allocation of omega-3 or placebo capsules for all randomized subjects and beginning of the week 0 of treatment.
Visit 3 Treatment week 4 Allocation of omega-3 or placebo capsules. Checking of adverse effects. Accounting of capsules. Supervision of compliance diary of omega-3 or placebo capsules. Supervision of compliance diary food recommendation. Supervision of compliance physical activity
Visit 4 Treatment week 8 Allocation of omega-3 or placebo capsules. Checking of adverse effects. Accounting of capsules. Supervision of compliance diary of omega-3 or placebo capsules. Supervision of compliance diary food recommendation. Supervision of compliance physical activity.
Visit 5 Treatment week 12 Checking of adverse effects. Accounting of capsules. Supervision of compliance diary of omega-3 or placebo capsules. Supervision of compliance diary food recommendation. Supervision of compliance physical activity.
Follow-up telephone call week 16. A follow-up telephone was performed 4 weeks after the visit 5. At the follow-up telephone call, the investigator checked adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Omega-3 fatty acid 3 grams per day | Experimental | Dietary Supplement: Omega-3 fatty acid 3 grams per dayEach 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboEach 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. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Ages 10-16 years old
- Informed consent from a parent or legal guardian of minors or adult subject
- Written assent from the adolescent to participate in the study
- Obese patients (Body Mass Index ≥95th percentile according to the National Center for Health Statistics, Center for Disease Control and Prevention [CDC].
- Fasting Serum triglycerides ≥150 mg/dL and ≤1000 mg/dL.
Key exclusion criteria (22 listed)
- The subjects must not had received pharmacology treatment for hypertriglyceridemia six months before and at the time of enrollment.
- Treatment with medications that affect triglyceride levels, including oral hypoglycemic agents or insulin.
- Pregnancy or positive urine pregnancy test for those females who have begun menstruating.
- Known Bleeding Disorder or Coagulopathy or treatment with anticoagulant medications or low platelet counts, abnormal PT, or PTT.
- Subjects with mental delayed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 fatty acid 3 grams per dayAlso: Omega-3Each 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. | Dietary supplement | Omega-3 fatty acid 3 grams per day |
| PlaceboAlso: Soybean oilPlacebo 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. | Dietary supplement | Placebo |
Primary outcome
Percentage Change in Serum Triglyceride Levels From Baseline to Week 12 of Study Treatment
Time frame: 12 weeks
Percentage change in serum triglyceride levels from baseline to week 12 of study treatment
Milligram Change in Serum Triglyceride Levels From Baseline to Week 12 of Study Treatment
Time frame: 12 weeks
Milligram Change in Serum Triglyceride Levels From Baseline to Week 12 of Study Treatment
8 secondary outcomes
Percentage Change in Serum Cholesterol Levels From Baseline to Week 12 of Study Treatment
Time frame: 12 weeks
Milligram Change in Serum Cholesterol Levels From Baseline to Week 12 of Study Treatment
Time frame: 12 weeks
Percentage Change in Serum HDL-C Levels From Baseline to Week 12 of Study Treatment
Time frame: 12 weeks
Milligram Change in Serum HDL-C Levels From Baseline to Week 12 of Study Treatment
Time frame: 12 weeks
Percentage Change in Serum Glucose Levels From Baseline to Week 12 of Study Treatment
Time frame: 12 weeks
Milligram Change in Glucose Levels From Baseline to Week 12 of Study Treatment
Time frame: 12 weeks
Percentage Change in Serum Uric Acid Levels From Baseline to Week 12 of Study Treatment
Time frame: 12 weeks
Milligram Change in Serum Uric Acid Levels From Baseline to Week 12 of Study Treatment
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 9865671Harris WS, Ginsberg HN, Arunakul N, Shachter NS, Windsor SL, Adams M, Berglund L, Osmundsen K. Safety and efficacy of Omacor in severe hypertriglyceridemia. J Cardiovasc Risk. 1997 Oct-Dec;4(5-6):385-91.
- Results publication: PubMed 9129504Harris WS. n-3 fatty acids and serum lipoproteins: human studies. Am J Clin Nutr. 1997 May;65(5 Suppl):1645S-1654S. doi: 10.1093/ajcn/65.5.1645S.
- Results publication: PubMed 18541599Jacobson TA. Role of n-3 fatty acids in the treatment of hypertriglyceridemia and cardiovascular disease. Am J Clin Nutr. 2008 Jun;87(6):1981S-90S. doi: 10.1093/ajcn/87.6.1981S.
- Results publication: PubMed 21502576Miller M, Stone NJ, Ballantyne C, Bittner V, Criqui MH, Ginsberg HN, Goldberg AC, Howard WJ, Jacobson MS, Kris-Etherton PM, Lennie TA, Levi M, Mazzone T, Pennathur S; American Heart Association Clinical Lipidology, Thrombosis, and Prevention Committee of the Council on Nutrition, Physical Activity, and Metabolism; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2011 May 24;123(20):2292-333. doi: 10.1161/CIR.0b013e3182160726. Epub 2011 Apr 18. No abstract available.
- Results publication: PubMed 27600795Su TC, Hwang JJ, Huang KC, Chiang FT, Chien KL, Wang KY, Charng MJ, Tsai WC, Lin LY, Vige R, Olivar JE, Tseng CD. A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Ethyl-Ester Omega-3 Fatty Acid in Taiwanese Hypertriglyceridemic Patients. J Atheroscler Thromb. 2017 Mar 1;24(3):275-289. doi: 10.5551/jat.34231. Epub 2016 Sep 6.
- Results publication: PubMed 24528690Kastelein JJ, Maki KC, Susekov A, Ezhov M, Nordestgaard BG, Machielse BN, Kling D, Davidson MH. Omega-3 free fatty acids for the treatment of severe hypertriglyceridemia: the EpanoVa fOr Lowering Very high triglyceridEs (EVOLVE) trial. J Clin Lipidol. 2014 Jan-Feb;8(1):94-106. doi: 10.1016/j.jacl.2013.10.003. Epub 2013 Oct 14.
- Results publication: PubMed 27910077Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Z, Riccardi G, Taskinen MR, Tokgozoglu L, Verschuren WM, Vlachopoulos C, Wood DA, Zamorano JL. [2016 ESC/EAS Guidelines for the Management of Dyslipidaemias]. Kardiol Pol. 2016;74(11):1234-1318. doi: 10.5603/KP.2016.0157. No abstract available. Polish.
- Results publication: PubMed 16530201Balk EM, Lichtenstein AH, Chung M, Kupelnick B, Chew P, Lau J. Effects of omega-3 fatty acids on serum markers of cardiovascular disease risk: a systematic review. Atherosclerosis. 2006 Nov;189(1):19-30. doi: 10.1016/j.atherosclerosis.2006.02.012. Epub 2006 Mar 10.
- Results publication: PubMed 18327998Bays HE, Tighe AP, Sadovsky R, Davidson MH. Prescription omega-3 fatty acids and their lipid effects: physiologic mechanisms of action and clinical implications. Expert Rev Cardiovasc Ther. 2008 Mar;6(3):391-409. doi: 10.1586/14779072.6.3.391.
- Results publication: PubMed 24239923Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2889-934. doi: 10.1016/j.jacc.2013.11.002. Epub 2013 Nov 12. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 fatty acid 3 grams per day in people with Hypertriglyceridemia and Pediatric Obesity, run by Hospital Infantil de Mexico Federico Gomez.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Serum Triglyceride Levels From Baseline to Week 12 of Study Treatment (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03216057, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.