Omega 3NCT07138131
Impact of Omega 3 in Treatment of Inappropriate Sinus Tachycardia
A study testing Omega 3 and Standard follow-up in people with Omega 3 and Treatment, run by Benha University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Omega 3, Treatment, Inappropriate Sinus Tachycardia
- What is being tested?
- Omega 3 and Standard follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
Inappropriate sinus tachycardia (IST) is a is a common disease of the autonomic nervous system in children in which tachyarrhythmia characterized by a persistent increase in resting sinus rate or disproportionate elevation of heart rate (HR) with minimal physiological effort accompanied by wide ranging symptoms including palpitations, fatigue, presyncope, and exercise intolerance it could cause lead to total disability in severe cases .it also takes a chronic course with Significant adverse effects on quality of life.
- Conditions
- Omega 3, Treatment, Inappropriate Sinus Tachycardia
- Being tested
- Omega 3, Standard follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3Drug
Patients received omega-3 supplementation for 3 months.
Standard follow-upOther
Patients received standard follow-up without treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients received omega-3 supplementation for 3 months. Receives: Drug: Omega 3 |
| Group B | Active comparator | Patients received standard follow-up without treatment. Receives: Other: Standard follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate was recorded at baseline and post-treatment.
Measured: 24 hours post-treatment
Secondary outcomes (1)
Heart rate variability (HRV)
Heart rate variability (HRV) was recorded at baseline and post-treatment.
Measured: 24 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Oct 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Omega 3Studies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yousra Mohsen kamal Ali El -Tabakh, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138131
- Sponsor's protocol ID
- MD 11-4-2023
- Status last verified
- Aug 2025
- First submitted
- 16 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Omega 3 in Treatment of Inappropriate Sinus Tachycardia
- ClinicalTrials.gov ID
- NCT07138131
- Acronym / sponsor ID
- MD 11-4-2023
- Conditions
- Omega 3, Treatment, Inappropriate Sinus Tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Inappropriate sinus tachycardia (IST) is a is a common disease of the autonomic nervous system in children in which tachyarrhythmia characterized by a persistent increase in resting sinus rate or disproportionate elevation of heart rate (HR) with minimal physiological effort accompanied by wide ranging symptoms including palpitations, fatigue, presyncope, and exercise intolerance it could cause lead to total disability in severe cases .it also takes a chronic course with Significant adverse effects on quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Omega 3Patients received omega-3 supplementation for 3 months. |
| Group B | Active comparator | Other: Standard follow-upPatients received standard follow-up without treatment. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3Patients received omega-3 supplementation for 3 months. | Drug | Group A |
| Standard follow-upPatients received standard follow-up without treatment. | Other | Group B |
Primary outcome
Heart rate
Time frame: 24 hours post-treatment
Heart rate was recorded at baseline and post-treatment.
1 secondary outcome
Heart rate variability (HRV)
Time frame: 24 hours post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega 3 and Standard follow-up in people with Omega 3 and Treatment, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: 24 hours post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.