Docosahexaenoic Acid on Breath Holding Spells in Children

NCT ID: NCT03965988

Last Updated: 2019-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2028-12-31

Brief Summary

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DHA on Breath Holding Spells

Detailed Description

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Effect of DHA on Breath Holding Spells

Conditions

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Breath Holding Attack

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Docosahexaenoic Acid

Docosahexaenoic acid

Group Type EXPERIMENTAL

DHA

Intervention Type DRUG

Docosahexaenoic acid

Placebo drug

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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DHA

Docosahexaenoic acid

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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Docosahexaenoic acid Placebo oral tablet

Eligibility Criteria

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Inclusion Criteria

* Children with newly diagnosed sprlls
Minimum Eligible Age

1 Month

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sherief Abd-Elsalam

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Ass. Prof. Tropical Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Amira Darwish, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Tanta University - Faculty of Medicine

Abeer Salamah, MD

Role: STUDY_DIRECTOR

Tanta University - Faculty of Medicine

Locations

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Sherief Abd-Elsalam

Tanta, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherief Abd-Elsalam, ass. prof.

Role: CONTACT

00201147773440

Facility Contacts

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Sherief Abd-Elsalam

Role: primary

References

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Salamah A, Darwish AH. Docosahexaenoic Acid Plus Piracetam Versus Piracetam Alone for Treatment of Breath-Holding Spells in Children: A Randomized Clinical Trial. Pediatr Neurol. 2023 Nov;148:32-36. doi: 10.1016/j.pediatrneurol.2023.08.003. Epub 2023 Aug 9.

Reference Type DERIVED
PMID: 37651975 (View on PubMed)

Other Identifiers

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breah holding

Identifier Type: -

Identifier Source: org_study_id

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