Impact of Omega 3 in Treatment of Inappropriate Sinus Tachycardia

NCT07138131 | Completed

• 1 other identifier: MD 11-4-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the effect of omega-3 supplementation on heart rate (HR) control and heart rate variability (HRV) in children with inappropriate sinus tachycardia (IST).

Conditions

Omega 3; Treatment; Inappropriate Sinus Tachycardia

Outcome Measures

Primary Outcomes (1)

• Heart rate

  Heart rate was recorded at baseline and post-treatment.

  24 hours post-treatment

Secondary Outcomes (1)

• Heart rate variability (HRV)

  24 hours post-treatment

Study Arms (2)

Group A

EXPERIMENTAL

Patients received omega-3 supplementation for 3 months.

Drug: Omega 3

Group B

ACTIVE COMPARATOR

Patients received standard follow-up without treatment.

Other: Standard follow-up

Interventions

Omega 3 DRUG

Patients received omega-3 supplementation for 3 months.

Group A

Standard follow-up OTHER

Patients received standard follow-up without treatment.

Group B

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age from 12 to 16 years.
• Both sexes.
• Patients diagnosed with inappropriate sinus tachycardia (IST).
• Patients with resting heart rate (HR) ≥100 bpm (sitting) and/or 24-hour average HR ≥90.

You may not qualify if:

• Structural heart disease.
• Patients receiving antiarrhythmic medication.
• Patients with a prior history of arrhythmias such as paroxysmal supraventricular tachycardia (PSVT) or sick sinus syndrome, or orthostatic hypotension.
• Secondary conditions such as anemia, infection, or hyperthyroidism.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, Al-Qalyubia, 13518, Egypt

Location

MeSH Terms

Interventions

Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Pediatrics and Neonatology, Faculty of Medicine, Benha University, Egypt.

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: August 22, 2025
• Study Start: October 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)