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Docosahexaenoic Acid on Breath Holding Spells in Children

Sponsor
Sherief Abd-Elsalam (Other)
Overall Status
Recruiting
CT.gov ID
NCT03965988
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
127
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

DHA on Breath Holding Spells

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Effect of DHA on Breath Holding Spells

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Docosahexaenoic Acid on Breath Holding Spells in Children: A Randomized Controlled Trial
Actual Study Start Date :
May 1, 2018
Anticipated Primary Completion Date :
Nov 1, 2028
Anticipated Study Completion Date :
Dec 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Docosahexaenoic Acid

Docosahexaenoic acid

Drug: DHA
Docosahexaenoic acid
Other Names:
  • Docosahexaenoic acid

    		•
    Placebo Comparator: Placebo drug

    Placebo

    Drug: Placebo
    Placebo
    Other Names:
  • Placebo oral tablet

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Frequency of the spells [6 months]

      Number of attacks

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 5 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Children with newly diagnosed sprlls

    Exclusion Criteria Other treatment as iron and piracetam

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sherief Abd-Elsalam Tanta Egypt

    Sponsors and Collaborators

    • Sherief Abd-Elsalam

    Investigators

    • Principal Investigator: Amira Darwish, Lecturer, Tanta University - Faculty of Medicine
    • Study Director: Abeer Salamah, MD, Tanta University - Faculty of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sherief Abd-Elsalam, Ass. Prof. Tropical Medicine, Tanta University
    ClinicalTrials.gov Identifier:
    NCT03965988
    Other Study ID Numbers:
    • breah holding
    First Posted:
    May 29, 2019
    Last Update Posted:
    May 29, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 29, 2019