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Completed

NCT Number: NCT02144389

Arachidonic Acid Treatment Against Schistosomiasis Infection in 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.

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Key information

Conditions

Schistosomiasis Bilharzia Helminthiasis Infections Parasitic Diseases Trematode Infections Vector Borne Diseases

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Liver Institute, Menoufiya University,, Shebin El-Kom, Monufia Governorate, Egypt

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Praziquantel (PZQ)

Drug

40 mg/kg, a single dose, administered orally

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

Other names: Praziquantel (generic), Biltricide, trematodicide

Arachidonic acid (ARA)

Dietary Supplement

ARA (40% of total fatty acid)

Other names: ARASCO, Microbial arachidonic acid-rich oil

PZQ+ARA

Dietary Supplement

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

Other names: ARASCO, praziquantel

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

dsm-firmenich Switzerland AG

Industry

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
May 22, 2014
Registry last updated
May 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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