Effect of Omega-3 Fatty Acids Supplementation on Hypertriglyceridemia in Pediatric Patients With Obesity.

NCT03216057 | Completed Results DMC

• 1 other identifier: HIM/2008/006
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypertriglyceridemia; Pediatric Obesity

Keywords

hypertriglyceridemia; pediatric obesity; omega 3

Outcome Measures

Primary Outcomes (2)

• 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

  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

  12 weeks

Secondary Outcomes (8)

• Percentage Change in Serum Cholesterol Levels From Baseline to Week 12 of Study Treatment

  12 weeks

• Milligram Change in Serum Cholesterol Levels From Baseline to Week 12 of Study Treatment

  12 weeks

• Percentage Change in Serum HDL-C Levels From Baseline to Week 12 of Study Treatment

  12 weeks

• Milligram Change in Serum HDL-C Levels From Baseline to Week 12 of Study Treatment

  12 weeks

• Percentage Change in Serum Glucose Levels From Baseline to Week 12 of Study Treatment

  12 weeks

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

Omega-3 fatty acid 3 grams per day DIETARY_SUPPLEMENT

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.

Also known as: Omega-3

Omega-3 fatty acid 3 grams per day

Placebo DIETARY_SUPPLEMENT

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.

Also known as: Soybean oil

Placebo

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hospital Infantil de Mexico Federico Gomez: lead

Related Publications (10)

• 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.

  PMID: 9865671 RESULT

• Harris 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.

  PMID: 9129504 RESULT

• Jacobson 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.

  PMID: 18541599 RESULT

• Miller 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.

  PMID: 21502576 RESULT

• Su 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.

  PMID: 27600795 RESULT

• Kastelein 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.

  PMID: 24528690 RESULT

• Catapano 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.

  PMID: 27910077 RESULT

• Balk 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.

  PMID: 16530201 RESULT

• Bays 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.

  PMID: 18327998 RESULT

• Stone 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.

  PMID: 24239923 RESULT

MeSH Terms

Conditions

Hypertriglyceridemia; Pediatric Obesity

Interventions

Docosahexaenoic Acids; Soybean Oil

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Blanca Estela Del Rio Navarro
• Organization: Hospital Infantil de Mexico Federico Gomez

leijamjj@gmail.com

+525552289917

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The Masking intervention had made for investigation subjects and researchers
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, double-blind, placebo-controlled clinical trial

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 13, 2017
• Study Start: May 20, 2008
• Primary Completion: November 22, 2016
• Study Completion: November 22, 2016
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share