Bilharzia, Schistosomiasis
Conditions
Keywords
Arachidonic acid, Bilharzia, Mansoni, Schistosomiasis, Polyunsaturated fatty acid
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.
Interventions
DRUGPraziquantel (PZQ)
40 mg/kg, a single dose, administered orally 1 g of corn/soybean oil (50%/50%), administered orally
DIETARY_SUPPLEMENTArachidonic acid (ARA)
ARA (40% of total fatty acid)
DIETARY_SUPPLEMENTPZQ+ARA
A single dose of PZQ administered seven days in advance of initial treatment with ARA.
Sponsors
National Liver Institute, Egypt
Cairo University
High Institute of Public Health, Egypt
DSM Nutritional Products, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent egg reduction | 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
| Measure | Time frame | Description |
|---|---|---|
| Biochemical and hematological parameters | Three days after a 15-day ARA supplementation | 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. |
| Total plasma phospholipids | Three days after 15-day ARA supplementation. | 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. |
Countries
Egypt
Outcome results
None listed