Title
Arachidonic Acid Treatment Against Schistosomiasis Infection in Children
Effects of Arachidonic Acid Supplementation on Schistosomiasis Mansoni Infection in Egyptian School Children
Phase
N/ALead Sponsor
DSMStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Schistosomiasis BilharziaIntervention/Treatment
arachidonic acid praziquantel ...Study Participants
335Randomized 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.
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.
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.
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