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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03216057
Recruitment Status : Completed
First Posted : July 13, 2017
Last Update Posted : July 13, 2017
Sponsor:
Collaborators:
Leija Martinez José de Jesús
Miranda Lora América Liliana
Hall Mondragon Margareth Sharon
Fengyang Huang
Information provided by (Responsible Party):
Blanca Estela Del Rio Navarro, Hospital Infantil de Mexico Federico Gomez

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.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Pediatric Obesity Dietary Supplement: Omega-3 fatty acid 3 grams per day Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled clinical trial
Masking: Double (Participant, Investigator)
Masking Description: The Masking intervention had made for investigation subjects and researchers
Primary Purpose: Treatment
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.
Actual Study Start Date : May 20, 2008
Actual Primary Completion Date : November 22, 2016
Actual Study Completion Date : November 22, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides

Arm Intervention/treatment
Experimental: 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 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
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.
Other Name: Omega-3

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.
Dietary Supplement: Placebo
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.
Other Name: Soybean oil




Primary Outcome Measures :
  1. Percent Change from baseline in Triglyceride [ Time Frame: 12 weeks ]
    Percent change in triglyceride from baseline to week 12 of study treatment

  2. Fasting Triglycerides [ Time Frame: 12 weeks ]
    Fasting Triglycerides from baseline to week 12 of study treatment


Secondary Outcome Measures :
  1. Percent Change from baseline in cholesterol [ Time Frame: 12 weeks ]
    Percent Change in cholesterol from baseline to week 12 of study treatment

  2. Fasting Cholesterol [ Time Frame: 12 weeks ]
    Fasting Cholesterol from baseline to week 12 of study treatment

  3. Percent Change from baseline in HDL-C [ Time Frame: 12 weeks ]
    Percent Change in HDL-C from baseline to week 12 of study treatment

  4. Fasting HDL-C [ Time Frame: 12 weeks ]
    Fasting HDL-C from baseline to week 12 of study treatment

  5. Percent Change from baseline in glucose [ Time Frame: 12 weeks ]
    Percent Change in glucose from baseline to week 12 of study treatment

  6. Fasting glucose [ Time Frame: 12 weeks ]
    Fasting glucose from baseline to week 12 of study treatment

  7. Percent Change from baseline in Uric Acid [ Time Frame: 12 weeks ]
    Percent Change in Uric Acid from baseline to week 12 of study treatment

  8. Fasting Uric Acid [ Time Frame: 12 weeks ]
    Fasting Uric Acid from baseline to week 12 of study treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Publications of Results:

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Responsible Party: Blanca Estela Del Rio Navarro, Allergy and Pediatric Clinical Immunology, Hospital Infantil de Mexico Federico Gomez
ClinicalTrials.gov Identifier: NCT03216057    
Other Study ID Numbers: HIM/2008/006
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Blanca Estela Del Rio Navarro, Hospital Infantil de Mexico Federico Gomez:
hypertriglyceridemia
pediatric obesity
omega 3
Additional relevant MeSH terms:
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Obesity
Hypertriglyceridemia
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases