Title

Arachidonic Acid Treatment Against Schistosomiasis Infection in Children
Effects of Arachidonic Acid Supplementation on Schistosomiasis Mansoni Infection in Egyptian School Children
  • Phase

    N/A
  • Lead Sponsor

    DSM
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    335
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 Started
Jan 31
2013
Primary Completion
Jul 31
2013
Study Completion
Jan 31
2014
Last Update
May 22
2014
Estimate

Drug Praziquantel (PZQ)

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

  • Other names: Praziquantel (generic), Biltricide, trematodicide

Dietary Supplement Arachidonic acid (ARA)

ARA (40% of total fatty acid)

  • Other names: ARASCO, Microbial arachidonic acid-rich oil

Dietary Supplement PZQ+ARA

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

  • Other names: ARASCO, praziquantel

Praziquantel (PZQ) Active Comparator

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.

Arachidonic acid (ARA) Experimental

A single daily dose of 1 g microbial arachidonic acid-rich oil administered orally for 15 consecutive days of school.

PZQ + ARA Experimental

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.

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
No Results Posted