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Arachidonic Acid Treatment Against Schistosomiasis Infection in Children

Primary Purpose

Schistosomiasis, Bilharzia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Praziquantel (PZQ)
Arachidonic acid (ARA)
PZQ+ARA
Sponsored by
DSM Nutritional Products, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schistosomiasis focused on measuring Arachidonic acid, Bilharzia, Mansoni, Schistosomiasis, Polyunsaturated fatty acid

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Liver Institute, Menoufiya University,
  • Tropical Health Department, High Institute of Public Health, Alexandria University
  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Praziquantel (PZQ)

Arachidonic acid (ARA)

PZQ + ARA

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

Percent egg reduction
Stool samples were collected from each child on three consecutive days to determine egg counts per gram of stool.

Secondary Outcome Measures

Biochemical and hematological parameters
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.
Total plasma phospholipids
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.

Full Information

First Posted
May 16, 2014
Last Updated
May 19, 2014
Sponsor
DSM Nutritional Products, Inc.
Collaborators
National Liver Institute, Egypt, Cairo University, High Institute of Public Health, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT02144389
Brief Title
Arachidonic Acid Treatment Against Schistosomiasis Infection in Children
Official Title
Effects of Arachidonic Acid Supplementation on Schistosomiasis Mansoni Infection in Egyptian School Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DSM Nutritional Products, Inc.
Collaborators
National Liver Institute, Egypt, Cairo University, High Institute of Public Health, Egypt

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schistosomiasis, Bilharzia
Keywords
Arachidonic acid, Bilharzia, Mansoni, Schistosomiasis, Polyunsaturated fatty acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
335 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Praziquantel (PZQ)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arachidonic acid (ARA)
Arm Type
Experimental
Arm Description
A single daily dose of 1 g microbial arachidonic acid-rich oil administered orally for 15 consecutive days of school.
Arm Title
PZQ + ARA
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Praziquantel (PZQ)
Other Intervention Name(s)
Praziquantel (generic), Biltricide, trematodicide
Intervention Description
40 mg/kg, a single dose, administered orally 1 g of corn/soybean oil (50%/50%), administered orally
Intervention Type
Dietary Supplement
Intervention Name(s)
Arachidonic acid (ARA)
Other Intervention Name(s)
ARASCO, Microbial arachidonic acid-rich oil
Intervention Description
ARA (40% of total fatty acid)
Intervention Type
Dietary Supplement
Intervention Name(s)
PZQ+ARA
Other Intervention Name(s)
ARASCO, praziquantel
Intervention Description
A single dose of PZQ administered seven days in advance of initial treatment with ARA.
Primary Outcome Measure Information:
Title
Percent egg reduction
Description
Stool samples were collected from each child on three consecutive days to determine egg counts per gram of stool.
Time Frame
4 weeks after end of 1 day PZQ treatment
Secondary Outcome Measure Information:
Title
Biochemical and hematological parameters
Description
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.
Time Frame
Three days after a 15-day ARA supplementation
Title
Total plasma phospholipids
Description
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.
Time Frame
Three days after 15-day ARA supplementation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rashika El Ridi
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sahar Selim, Ph.D.
Organizational Affiliation
National Liver Institute, Menoufiya University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rashida Barakat, Ph.D.
Organizational Affiliation
High Institute of Public Health, Alexandria University
Official's Role
Study Director
Facility Information:
Facility Name
National Liver Institute, Menoufiya University,
City
Shebin El-Kom
State/Province
Menoufiya
Country
Egypt
Facility Name
Tropical Health Department, High Institute of Public Health, Alexandria University
City
Alexandria
Country
Egypt
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
25624403
Citation
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.
Results Reference
derived

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Arachidonic Acid Treatment Against Schistosomiasis Infection in Children

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