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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
335
40 mg/kg, a single dose, administered orally 1 g of corn/soybean oil (50%/50%), administered orally
ARA (40% of total fatty acid)
A single dose of PZQ administered seven days in advance of initial treatment with ARA.
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
Percent egg reduction
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
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.
Time frame: 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.
Time frame: Three days after 15-day ARA supplementation.
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