An efficacy and safety comparison study of Fenofibrate and omega 3 in pediatric patients with Hypertriglyceridemia, A Randomized Clinical Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220516054879N4

Enrollment

Registered

2023-01-21

Start date

2023-01-21

Completion date

Unknown

Last updated

2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia. Pure hyperglyceridemia, Endogenous hyperglyceridemia

Interventions

Intervention 1: Intervention group : In addition to following the diet, they also receive fenofibrate 100 mg once a day after lunch for 12 weeks. Intervention 2: Intervention group: In addition to fol

Eligibility

Sex/Gender

All

Age

8 Years to 18 Years

Inclusion criteria

Inclusion criteria: 8-12 years old Patients with hypertriglyceridemia, with triglyceride more than 400mg/dl or triglyceride more than 250mg/dl that are intended to use medication or not responded to diet and exercise.

Exclusion criteria

Exclusion criteria: Patient reluctance Patient treated with statins or ezetimibe Pragnancy Acute or chronic pancreatitis

Design outcomes

Primary

Measure	Time frame
Fasting blood triglycerides. Timepoint: The variable will be measured at the beginning of the study, 8 and 12 weeks after the start of the study. Method of measurement: Blood tests.;Fasting blood LDL level. Timepoint: The variable will be measured at the beginning of the study, 8 and 12 weeks after the start of the study. Method of measurement: Blood tests.;Fasting blood cholesterol. Timepoint: The variable will be measured at the beginning of the study, 8 and 12 weeks after the start of the study. Method of measurement: Blood tests.	—

Measure

Time frame

Fasting blood triglycerides. Timepoint: The variable will be measured at the beginning of the study, 8 and 12 weeks after the start of the study. Method of measurement: Blood tests.;Fasting blood LDL level. Timepoint: The variable will be measured at the beginning of the study, 8 and 12 weeks after the start of the study. Method of measurement: Blood tests.;Fasting blood cholesterol. Timepoint: The variable will be measured at the beginning of the study, 8 and 12 weeks after the start of the study. Method of measurement: Blood tests.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Shahrokhi

Rasht University of Medical Sciences

shahrokhi.mail85@gmail.com0098133369019

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026