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Safety and Efficacy of Omega-3 Free Fatty Acids in Adolescents With Obesity and Hypertriglyceridemia.

Primary Purpose

Hypertriglyceridemia, Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Omega-3 fatty acid 3 grams per day
Placebo
Sponsored by
Hospital Infantil de Mexico Federico Gomez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia focused on measuring hypertriglyceridemia, pediatric obesity, omega 3

Eligibility Criteria

10 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 Cardiophaty
  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Omega-3 fatty acid 3 grams per day

    Placebo

    Arm Description

    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.

    Each capsule contains 600 mg of soybean oil. We allocated five capusles 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.

    Outcomes

    Primary Outcome Measures

    Percent Change from baseline in Triglyceride
    Percent change in triglyceride from baseline to week 12 of study treatment
    Fasting Triglycerides
    Fasting Triglycerides from baseline to week 12 of study treatment

    Secondary Outcome Measures

    Percent Change from baseline in cholesterol
    Percent Change in cholesterol from baseline to week 12 of study treatment
    Fasting Cholesterol
    Fasting Cholesterol from baseline to week 12 of study treatment
    Percent Change from baseline in HDL-C
    Percent Change in HDL-C from baseline to week 12 of study treatment
    Fasting HDL-C
    Fasting HDL-C from baseline to week 12 of study treatment
    Percent Change from baseline in glucose
    Percent Change in glucose from baseline to week 12 of study treatment
    Fasting glucose
    Fasting glucose from baseline to week 12 of study treatment
    Percent Change from baseline in Uric Acid
    Percent Change in Uric Acid from baseline to week 12 of study treatment
    Fasting Uric Acid
    Fasting Uric Acid from baseline to week 12 of study treatment

    Full Information

    First Posted
    July 10, 2017
    Last Updated
    July 10, 2017
    Sponsor
    Hospital Infantil de Mexico Federico Gomez
    Collaborators
    Leija Martinez José de Jesús, Miranda Lora América Liliana, Hall Mondragon Margareth Sharon, Fengyang Huang
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03216057
    Brief Title
    Safety and Efficacy of Omega-3 Free Fatty Acids in Adolescents With Obesity and Hypertriglyceridemia.
    Official Title
    A Randomized, Double Blind, Placebo-controlled Clinical Trial to Assess the Safety and Efficacy of Omega-3 Free Fatty Acids in Adolescents With Obesity and Hypertriglyceridemia.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 20, 2008 (Actual)
    Primary Completion Date
    November 22, 2016 (Actual)
    Study Completion Date
    November 22, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Infantil de Mexico Federico Gomez
    Collaborators
    Leija Martinez José de Jesús, Miranda Lora América Liliana, Hall Mondragon Margareth Sharon, Fengyang Huang

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The primary objetive 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 triacylgycerol 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 triacylgylcerol synthesis results in lowering plasma triacylgycerol 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 hypetriglyceridemia (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 hypertrigyceridemia 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertriglyceridemia, Pediatric Obesity
    Keywords
    hypertriglyceridemia, pediatric obesity, omega 3

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized, double-blind, placebo-controlled clinical trial
    Masking
    ParticipantInvestigator
    Masking Description
    The Masking intervention had made for investigation subjects and researchers
    Allocation
    Randomized
    Enrollment
    168 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Omega-3 fatty acid 3 grams per day
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Each capsule contains 600 mg of soybean oil. We allocated five capusles 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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Omega-3 fatty acid 3 grams per day
    Other Intervention Name(s)
    Omega-3
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Soybean oil
    Intervention Description
    Placebo Comparator: Placebo Each capsule contains 600 mg of soybean oil. We allocated five capusles 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.
    Primary Outcome Measure Information:
    Title
    Percent Change from baseline in Triglyceride
    Description
    Percent change in triglyceride from baseline to week 12 of study treatment
    Time Frame
    12 weeks
    Title
    Fasting Triglycerides
    Description
    Fasting Triglycerides from baseline to week 12 of study treatment
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Percent Change from baseline in cholesterol
    Description
    Percent Change in cholesterol from baseline to week 12 of study treatment
    Time Frame
    12 weeks
    Title
    Fasting Cholesterol
    Description
    Fasting Cholesterol from baseline to week 12 of study treatment
    Time Frame
    12 weeks
    Title
    Percent Change from baseline in HDL-C
    Description
    Percent Change in HDL-C from baseline to week 12 of study treatment
    Time Frame
    12 weeks
    Title
    Fasting HDL-C
    Description
    Fasting HDL-C from baseline to week 12 of study treatment
    Time Frame
    12 weeks
    Title
    Percent Change from baseline in glucose
    Description
    Percent Change in glucose from baseline to week 12 of study treatment
    Time Frame
    12 weeks
    Title
    Fasting glucose
    Description
    Fasting glucose from baseline to week 12 of study treatment
    Time Frame
    12 weeks
    Title
    Percent Change from baseline in Uric Acid
    Description
    Percent Change in Uric Acid from baseline to week 12 of study treatment
    Time Frame
    12 weeks
    Title
    Fasting Uric Acid
    Description
    Fasting Uric Acid from baseline to week 12 of study treatment
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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 Cardiophaty 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    9865671
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    9129504
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    18541599
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    21502576
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    27600795
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    24528690
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    27910077
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    16530201
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    18327998
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    24239923
    Citation
    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. Erratum In: J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):3024-3025. J Am Coll Cardiol. 2015 Dec 22;66(24):2812.
    Results Reference
    result

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    Safety and Efficacy of Omega-3 Free Fatty Acids in Adolescents With Obesity and Hypertriglyceridemia.

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