Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Arachidonic Acid Treatment Against Schistosomiasis Infection in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02144389
Recruitment Status : Completed
First Posted : May 22, 2014
Last Update Posted : May 22, 2014
Sponsor:
Collaborators:
National Liver Institute, Egypt
Cairo University
High Institute of Public Health, Egypt
Information provided by (Responsible Party):
DSM Nutritional Products, Inc.

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.

Condition or disease Intervention/treatment Phase
Schistosomiasis Bilharzia Drug: Praziquantel (PZQ) Dietary Supplement: Arachidonic acid (ARA) Dietary Supplement: PZQ+ARA Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 335 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Other Names:
  • Praziquantel (generic)
  • Biltricide
  • trematodicide

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)
Other Names:
  • ARASCO
  • Microbial arachidonic acid-rich oil

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.
Other Names:
  • ARASCO
  • praziquantel




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Egypt
National Liver Institute, Menoufiya University,
Shebin El-Kom, Menoufiya, Egypt
Tropical Health Department, High Institute of Public Health, Alexandria University
Alexandria, Egypt
Cairo University
Cairo, Egypt
Sponsors and Collaborators
DSM Nutritional Products, Inc.
National Liver Institute, Egypt
Cairo University
High Institute of Public Health, Egypt
Investigators
Layout table for investigator information
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier: NCT02144389    
Other Study ID Numbers: 2012-1054
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: May 2014
Keywords provided by DSM Nutritional Products, Inc.:
Arachidonic acid
Bilharzia
Mansoni
Schistosomiasis
Polyunsaturated fatty acid
Additional relevant MeSH terms:
Layout table for MeSH terms
Schistosomiasis
Trematode Infections
Helminthiasis
Parasitic Diseases
Praziquantel
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents