Arachidonic Acid Treatment Against Schistosomiasis Infection in Children
NCT ID: NCT02144389
Last Updated: 2014-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
335 participants
INTERVENTIONAL
2013-01-31
2014-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Praziquantel (PZQ)
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.
Praziquantel (PZQ)
40 mg/kg, a single dose, administered orally
1 g of corn/soybean oil (50%/50%), administered orally
Arachidonic acid (ARA)
A single daily dose of 1 g microbial arachidonic acid-rich oil administered orally for 15 consecutive days of school.
Arachidonic acid (ARA)
ARA (40% of total fatty acid)
PZQ + ARA
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.
PZQ+ARA
A single dose of PZQ administered seven days in advance of initial treatment with ARA.
Interventions
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Praziquantel (PZQ)
40 mg/kg, a single dose, administered orally
1 g of corn/soybean oil (50%/50%), administered orally
Arachidonic acid (ARA)
ARA (40% of total fatty acid)
PZQ+ARA
A single dose of PZQ administered seven days in advance of initial treatment with ARA.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* clinically confirmed schistosomiasis
Exclusion Criteria
* less than 6 or greater than 15 years of age
6 Years
15 Years
ALL
No
Sponsors
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National Liver Institute, Egypt
OTHER
Cairo University
OTHER
High Institute of Public Health, Egypt
OTHER
DSM Nutritional Products, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rashika El Ridi
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Sahar Selim, Ph.D.
Role: STUDY_DIRECTOR
National Liver Institute, Menoufiya University
Rashida Barakat, Ph.D.
Role: STUDY_DIRECTOR
High Institute of Public Health, Alexandria University
Locations
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National Liver Institute, Menoufiya University,
Shebin El-Kom, Monufia Governorate, Egypt
Tropical Health Department, High Institute of Public Health, Alexandria University
Alexandria, , Egypt
Cairo University
Cairo, , Egypt
Countries
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References
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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.
Other Identifiers
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2012-1054
Identifier Type: -
Identifier Source: org_study_id
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