N/A
N=130
Effect of Omega-3 Fatty Acids Supplementation on Hypertriglyceridemia in Pediatric Patients With Obesity.
Hypertriglyceridemia · Pediatric Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03216057 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Percentage Change in Serum Triglyceride Levels From Baseline to Week 12 of Study Treatment — -39.1; -14.6 Percent change (%) — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Omega-3 fatty acid 3 grams per day (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- Hospital Infantil de Mexico Federico Gomez
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Serum Triglyceride Levels From Baseline to Week 12 of Study Treatment |
-39.1; -14.6 | <0.01 sig |
| PRIMARY Milligram Change in Serum Triglyceride Levels From Baseline to Week 12 of Study Treatment |
127.7; 187.6 | <0.01 sig |
| SECONDARY Percentage Change in Serum Cholesterol Levels From Baseline to Week 12 of Study Treatment |
-2.9; 6.1 | 0.01 sig |
| SECONDARY Milligram Change in Serum Cholesterol Levels From Baseline to Week 12 of Study Treatment |
157.4; 162.4 | 0.3 |
| SECONDARY Percentage Change in Serum HDL-C Levels From Baseline to Week 12 of Study Treatment |
3.8; 16.2 | <0.01 sig |
| SECONDARY Milligram Change in Serum HDL-C Levels From Baseline to Week 12 of Study Treatment |
34.4; 36.7 | 0.02 sig |
| SECONDARY Percentage Change in Serum Glucose Levels From Baseline to Week 12 of Study Treatment |
-0.4; 0.7 | 0.6 |
| SECONDARY Milligram Change in Glucose Levels From Baseline to Week 12 of Study Treatment |
86.1; 84.1 | 0.1 |
| SECONDARY Percentage Change in Serum Uric Acid Levels From Baseline to Week 12 of Study Treatment |
-1.9; -15.3 | <0.01 sig |
| SECONDARY Milligram Change in Serum Uric Acid Levels From Baseline to Week 12 of Study Treatment |
5.7; 4.8 | <0.01 sig |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT03216057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.