Safety and Efficacy of Omega-3 Free Fatty Acids in Adolescents With Obesity and Hypertriglyceridemia.
Hypertriglyceridemia, Pediatric Obesity
About this trial
This is an interventional treatment trial for Hypertriglyceridemia focused on measuring hypertriglyceridemia, pediatric obesity, omega 3
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Omega-3 fatty acid 3 grams per day
Placebo
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.