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| Name | Class |
|---|---|
| National Liver Institute, Egypt | OTHER |
| Cairo University | OTHER |
| High Institute of Public Health, Egypt | OTHER |
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Randomized Controlled Trial:
The investigational materials used in this trial were administered to subjects each day by trained clinicians.
Primary Objectives:
Secondary objective:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Praziquantel (PZQ) | Active Comparator | 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. |
|
| Arachidonic acid (ARA) | Experimental | A single daily dose of 1 g microbial arachidonic acid-rich oil administered orally for 15 consecutive days of school. |
|
| PZQ + ARA | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Praziquantel (PZQ) | Drug | 40 mg/kg, a single dose, administered orally 1 g of corn/soybean oil (50%/50%), administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent egg reduction | Stool samples were collected from each child on three consecutive days to determine egg counts per gram of stool. | 4 weeks after end of 1 day PZQ treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Three days after a 15-day ARA supplementation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rashika El Ridi | Cairo University | Principal Investigator |
| Sahar Selim, Ph.D. | National Liver Institute, Menoufiya University | Study Director |
| Rashida Barakat, Ph.D. | High Institute of Public Health, Alexandria University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Liver Institute, Menoufiya University, | Shebin El-Kom | Monufia Governorate | Egypt | |||
| Tropical Health Department, High Institute of Public Health, Alexandria University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25624403 | Derived | Barakat R, Abou El-Ela NE, Sharaf S, El Sagheer O, Selim S, Tallima H, Bruins MJ, Hadley KB, El Ridi R. Efficacy and safety of arachidonic acid for treatment of school-age children in Schistosoma mansoni high-endemicity regions. Am J Trop Med Hyg. 2015 Apr;92(4):797-804. doi: 10.4269/ajtmh.14-0675. Epub 2015 Jan 26. |
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| ID | Term |
|---|---|
| D012552 | Schistosomiasis |
| ID | Term |
|---|---|
| D014201 | Trematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D011223 | Praziquantel |
| D016568 | Drugs, Generic |
| D016718 | Arachidonic Acid |
| ID | Term |
|---|---|
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Arachidonic acid (ARA) | Dietary Supplement | ARA (40% of total fatty acid) |
|
|
| PZQ+ARA | Dietary Supplement | A single dose of PZQ administered seven days in advance of initial treatment with ARA. |
|
|
| 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. | Three days after 15-day ARA supplementation. |
| Alexandria |
| Egypt |
| Cairo University | Cairo | Egypt |
| D000079426 |
| Vector Borne Diseases |
| D004364 | Pharmaceutical Preparations |
| D001095 | Arachidonic Acids |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D005228 | Fatty Acids, Essential |