NCT03965988

Brief Summary

DHA on Breath Holding Spells

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
31mo left

Started May 2018

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
May 2018Dec 2028

Study Start

First participant enrolled

May 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

10.5 years

First QC Date

May 24, 2019

Last Update Submit

May 24, 2019

Conditions

Breath Holding Attack

Outcome Measures

Primary Outcomes (1)

  • Frequency of the spells

    Number of attacks

    6 months

Study Arms (2)

Docosahexaenoic Acid

EXPERIMENTAL

Docosahexaenoic acid

Drug: DHA

Placebo drug

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

DHADRUG

Docosahexaenoic acid

Also known as: Docosahexaenoic acid
Docosahexaenoic Acid
PlaceboDRUG

Placebo

Also known as: Placebo oral tablet
Placebo drug

Eligibility Criteria

Age1 Month - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with newly diagnosed sprlls

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37651975DERIVED

MeSH Terms

Interventions

Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Amira Darwish, Lecturer

    Tanta University - Faculty of Medicine

    PRINCIPAL INVESTIGATOR

  • Abeer Salamah, MD

    Tanta University - Faculty of Medicine

    STUDY DIRECTOR

Central Study Contacts

Sherief Abd-Elsalam, ass. prof.

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

May 24, 2019

First Posted

May 29, 2019

Study Start

May 1, 2018

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

May 29, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)