NCT02144389

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
335

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

6 months

First QC Date

May 16, 2014

Last Update Submit

May 19, 2014

Conditions

SchistosomiasisBilharzia

Keywords

Arachidonic acidBilharziaMansoniSchistosomiasisPolyunsaturated fatty acid

Outcome Measures

Primary Outcomes (1)

  • Percent egg reduction

    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 Outcomes (2)

  • Biochemical and hematological parameters

    Three days after a 15-day ARA supplementation

  • Total plasma phospholipids

    Three days after 15-day ARA supplementation.

Study Arms (3)

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.

Drug: Praziquantel (PZQ)

Arachidonic acid (ARA)

EXPERIMENTAL

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)

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.

Dietary Supplement: PZQ+ARA

Interventions

Praziquantel (PZQ)DRUG

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

Also known as: Praziquantel (generic), Biltricide, trematodicide
Praziquantel (PZQ)
Arachidonic acid (ARA)DIETARY_SUPPLEMENT

ARA (40% of total fatty acid)

Also known as: ARASCO, Microbial arachidonic acid-rich oil
Arachidonic acid (ARA)
PZQ+ARADIETARY_SUPPLEMENT

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

Also known as: ARASCO, praziquantel
PZQ + ARA

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • consent from parent or legal guardian
  • clinically confirmed schistosomiasis

You may not qualify if:

  • not infected with schistosomiasis
  • less than 6 or greater than 15 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National Liver Institute, Menoufiya University,

Shebin El-Kom, Monufia Governorate, Egypt

Location

Tropical Health Department, High Institute of Public Health, Alexandria University

Alexandria, Egypt

Location

Cairo University

Cairo, Egypt

Location

Related Publications (1)

  • Barakat R, Abou El-Ela NE, Sharaf S, El Sagheer O, Selim S, Tallima H, Bruins MJ, Hadley KB, El Ridi R. Efficacy and safety of arachidonic acid for treatment of school-age children in Schistosoma mansoni high-endemicity regions. Am J Trop Med Hyg. 2015 Apr;92(4):797-804. doi: 10.4269/ajtmh.14-0675. Epub 2015 Jan 26.

    PMID: 25624403DERIVED

MeSH Terms

Conditions

Schistosomiasis

Interventions

PraziquantelDrugs, GenericArachidonic Acid

Condition Hierarchy (Ancestors)

Trematode InfectionsHelminthiasisParasitic DiseasesInfectionsVector Borne Diseases

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPharmaceutical PreparationsArachidonic AcidsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsFatty Acids, Essential

Study Officials

  • Rashika El Ridi

    Cairo University

    PRINCIPAL INVESTIGATOR

  • Sahar Selim, Ph.D.

    National Liver Institute, Menoufiya University

    STUDY DIRECTOR

  • Rashida Barakat, Ph.D.

    High Institute of Public Health, Alexandria University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2014

First Posted

May 22, 2014

Study Start

January 1, 2013

Primary Completion

July 1, 2013

Study Completion

January 1, 2014

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

EG(3)