Arachidonic Acid Treatment Against Schistosomiasis Infection in Children
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|ClinicalTrials.gov Identifier: NCT02144389|
Recruitment Status : Completed
First Posted : May 22, 2014
Last Update Posted : May 22, 2014
Randomized Controlled Trial:
The investigational materials used in this trial were administered to subjects each day by trained clinicians.
- 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.
- to measure changes in total phospholipids in plasma.
|Condition or disease||Intervention/treatment||Phase|
|Schistosomiasis Bilharzia||Drug: Praziquantel (PZQ) Dietary Supplement: Arachidonic acid (ARA) Dietary Supplement: PZQ+ARA||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||335 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Effects of Arachidonic Acid Supplementation on Schistosomiasis Mansoni Infection in Egyptian School Children|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||January 2014|
Active Comparator: 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.
Drug: Praziquantel (PZQ)
40 mg/kg, a single dose, administered orally
1 g of corn/soybean oil (50%/50%), administered orally
Experimental: Arachidonic acid (ARA)
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)
ARA (40% of total fatty acid)
Experimental: 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.
Dietary Supplement: PZQ+ARA
A single dose of PZQ administered seven days in advance of initial treatment with ARA.
- 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.
- Biochemical and hematological parameters [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02144389
|National Liver Institute, Menoufiya University,|
|Shebin El-Kom, Menoufiya, Egypt|
|Tropical Health Department, High Institute of Public Health, Alexandria University|
|Principal Investigator:||Rashika El Ridi||Cairo University|
|Study Director:||Sahar Selim, Ph.D.||National Liver Institute, Menoufiya University|
|Study Director:||Rashida Barakat, Ph.D.||High Institute of Public Health, Alexandria University|