Arachidonic Acid Treatment Against Schistosomiasis Infection in Children

Study Overview
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Brief Summary
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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.

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

Conditions
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Schistosomiasis, Bilharzia

Intervention / Treatment
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* Drug: Praziquantel (PZQ)
* Dietary Supplement: Arachidonic acid (ARA)
* Dietary Supplement: PZQ+ARA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Praziquantel (PZQ)<br>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)<br>* 40 mg/kg, a single dose, administered orally 1 g of corn/soybean oil (50%/50%), administered orally<br>* Other names: trematodicide;|
| Experimental: Arachidonic acid (ARA)<br>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)<br>* ARA (40% of total fatty acid)<br>* Other names: Microbial arachidonic acid-rich oil;|
| Experimental: PZQ + ARA<br>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<br>* A single dose of PZQ administered seven days in advance of initial treatment with ARA.<br>* Other names: praziquantel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Three days after a 15-day ARA supplementation | 
| 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. | Three days after 15-day ARA supplementation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mansoni, Schistosomiasis, Polyunsaturated fatty acid, Arachidonic acid, Bilharzia