Effects of Arachidonic Acid Supplementation on Schistosomiasis Mansoni Infection in Egyptian School Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 335
- Locations
- 3
- Primary Endpoint
- Percent egg reduction
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Praziquantel (PZQ) (Drug)
Arachidonic acid (ARA)
A single daily dose of 1 g microbial arachidonic acid-rich oil administered orally for 15 consecutive days of school.
Intervention: Arachidonic acid (ARA) (Dietary Supplement)
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.
Intervention: PZQ+ARA (Dietary Supplement)
Outcomes
Primary Outcomes
Percent egg reduction
Time Frame: 4 weeks after end of 1 day PZQ treatment
Stool samples were collected from each child on three consecutive days to determine egg counts per gram of stool.
Secondary Outcomes
- Total plasma phospholipids(Three days after 15-day ARA supplementation.)
- Biochemical and hematological parameters(Three days after a 15-day ARA supplementation)