Docosahexaenoic Acid on Breath Holding Spells in Children | NCT03965988

Studies
Docosahexaenoic Acid on Breath Holding Spells in Children

NCT03965988

Sponsor

Sherief Abd-Elsalam

Status

Recruiting

Last Update Posted

May 29, 2019Actual

Enrollment

60Estimated

Phase

Phase 3

Conditions

Breath Holding Attack

Interventions

DHA
Placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2018Actual

Primary Completion Date

Nov 2028Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

May 24, 2019

First Submission Date that Met QC Criteria

May 24, 2019

First Posted Date

May 29, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2019

Last Update Posted Date

May 29, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Docosahexaenoic Acid	Experimental	Docosahexaenoic acid	Drug: DHA
Placebo drug	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DHA	Drug	Docosahexaenoic acid	Docosahexaenoic Acid	Docosahexaenoic acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of the spells	Number of attacks	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children with newly diagnosed sprlls

Exclusion Criteria Other treatment as iron and piracetam

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherief Abd-Elsalam, ass. prof.	Contact	00201147773440		sheriefabdelsalam@yahoo.com

Overall Officials

Name	Affiliation	Role
Amira Darwish, Lecturer	Tanta University - Faculty of Medicine	Principal Investigator
Abeer Salamah, MD	Tanta University - Faculty of Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sherief Abd-Elsalam	Recruiting	Tanta			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37651975	Derived	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.

ID	Term
D015525	Fatty Acids, Omega-3
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats