Arachidonic Acid Treatment Against Schistosomiasis Infection in Children

May 19, 2014 updated by: DSM Nutritional Products, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

335

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Tropical Health Department, High Institute of Public Health, Alexandria University
      • Cairo, Egypt
        • Cairo University
    • Menoufiya
      • Shebin El-Kom, Menoufiya, Egypt
        • National Liver Institute, Menoufiya University,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Praziquantel (PZQ)
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.
Drug: Praziquantel (PZQ)

40 mg/kg, a single dose, administered orally

1 g of corn/soybean oil (50%/50%), administered orally

Other Names:
  • Biltricide
  • Praziquantel (generic)
  • trematodicide
EXPERIMENTAL: Arachidonic acid (ARA)
A single daily dose of 1 g microbial arachidonic acid-rich oil administered orally for 15 consecutive days of school.
Dietary supplement: Arachidonic acid (ARA)
ARA (40% of total fatty acid)
Other Names:
  • ARASCO
  • Microbial arachidonic acid-rich oil
EXPERIMENTAL: PZQ + ARA
A single dose of PZQ (40 mg/kg) was administered orally on day-1 only, and after 7 days, followed the next day by 1 g of microbial ARA-rich oil, administered orally as a single dose on 15 consecutive days of school.
Dietary supplement: PZQ+ARA
A single dose of PZQ administered seven days in advance of initial treatment with ARA.
Other Names:
  • ARASCO
  • praziquantel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent egg reduction
Time Frame: 4 weeks after end of 1 day PZQ treatment
Stool samples were collected from each child on three consecutive days to determine egg counts per gram of stool.
4 weeks after end of 1 day PZQ treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical and hematological parameters
Time Frame: Three days after a 15-day ARA supplementation
Blood samples were collected using 4 vacutainer tubes. Serum was used to measure enzyme markers of liver and kidney functions. Coagulation tests included prothrombin- and activated thromboplastin times were measured using citrated blood. Complete hematological profiles were obtained using EDTA-anticoagulated blood samples.
Three days after a 15-day ARA supplementation
Total plasma phospholipids
Time Frame: Three days after 15-day ARA supplementation.
Blood samples (10 ml) were collected 2-3 days before the start of treatment, and 3 days after completion of treatment with ARA or PZQ+ARA for analysis of the phospholipids in plasma.
Three days after 15-day ARA supplementation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DSM Nutritional Products, Inc.

Collaborators

Cairo University
National Liver Institute, Egypt
High Institute of Public Health, Egypt

Investigators

  • Principal Investigator: Rashika El Ridi, Cairo University
  • Study Director: Sahar Selim, Ph.D., National Liver Institute, Menoufiya University
  • Study Director: Rashida Barakat, Ph.D., High Institute of Public Health, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

May 16, 2014

First Submitted That Met QC Criteria

May 19, 2014

First Posted (ESTIMATE)

May 22, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 22, 2014

Last Update Submitted That Met QC Criteria

May 19, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-1054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schistosomiasis

Clinical Trials on Praziquantel (PZQ)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe