Arachidonic Acid Treatment Against Schistosomiasis Infection in Children

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Brief Title

Arachidonic Acid Treatment Against Schistosomiasis Infection in Children

Official Title

Effects of Arachidonic Acid Supplementation on Schistosomiasis Mansoni Infection in Egyptian School Children

Brief Summary

      Randomized Controlled Trial:

      The investigational materials used in this trial were administered to subjects each day by
      trained clinicians.

      Primary Objectives:

        -  assess the effect of dietary supplementation with arachidonic acid on the cure rates for
           Schistosomiasis mansoni with and without concomitant treatment with praziquantel.

        -  assess the safety of dietary supplementation using arachidonic acid in children with
           clinically confirmed schistosomiasis mansoni infection.

      Secondary objective:

        -  to measure changes in total phospholipids in plasma.
    



Study Type

Interventional


Primary Outcome

Percent egg reduction

Secondary Outcome

 Biochemical and hematological parameters

Condition

Schistosomiasis

Intervention

Praziquantel (PZQ)

Study Arms / Comparison Groups

 Praziquantel (PZQ)
Description:  A single dose of praziquantel (40 mg/kg) was administered orally on day-1 only, and after 7 days, 1 g of corn oil/soybean oil (50%/50%), for 15 consecutive days of school.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

335

Start Date

January 2013

Completion Date

January 2014

Primary Completion Date

July 2013

Eligibility Criteria

        Inclusion Criteria:

          -  consent from parent or legal guardian

          -  clinically confirmed schistosomiasis

        Exclusion Criteria:

          -  not infected with schistosomiasis

          -  less than 6 or greater than 15 years of age
      

Gender

All

Ages

6 Years - 15 Years

Accepts Healthy Volunteers

No

Contacts

Rashika El Ridi, , 

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT02144389

Organization ID

2012-1054


Responsible Party

Sponsor

Study Sponsor

DSM Nutritional Products, Inc.

Collaborators

 National Liver Institute, Egypt

Study Sponsor

Rashika El Ridi, Principal Investigator, Cairo University


Verification Date

May 2014