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Arachidonic Acid Treatment Against Schistosomiasis Infection in Children

NCT02144389 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 335

Last updated 2014-05-22

No results posted yet for this study

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.

Conditions

  • Schistosomiasis
  • Bilharzia

Interventions

DRUG

Praziquantel (PZQ)

40 mg/kg, a single dose, administered orally 1 g of corn/soybean oil (50%/50%), administered orally

DIETARY_SUPPLEMENT

Arachidonic acid (ARA)

ARA (40% of total fatty acid)

DIETARY_SUPPLEMENT

PZQ+ARA

A single dose of PZQ administered seven days in advance of initial treatment with ARA.

Sponsors & Collaborators

  • National Liver Institute, Egypt

    collaborator OTHER

  • Cairo University

    collaborator OTHER

  • High Institute of Public Health, Egypt

    collaborator OTHER

  • DSM Nutritional Products, Inc.

    lead INDUSTRY

Principal Investigators

  • Rashika El Ridi · Cairo University

  • Sahar Selim, Ph.D. · National Liver Institute, Menoufiya University

  • Rashida Barakat, Ph.D. · High Institute of Public Health, Alexandria University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-07-31
Completion
2014-01-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02144389 on ClinicalTrials.gov