Arachidonic Acid Treatment Against Schistosomiasis Infection in Children

Schistosomiasis Clinical Trial

Official title:

Effects of Arachidonic Acid Supplementation on Schistosomiasis Mansoni Infection in Egyptian School Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02144389
• Other study ID #: 2012-1054
• Status: Completed
• Phase: N/A
• First received: May 16, 2014
• Last updated: May 19, 2014
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: May 2014
• Source: DSM Nutritional Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: January 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bilharzia
• Schistosomiasis

Intervention

Drug:
• Praziquantel (PZQ)
40 mg/kg, a single dose, administered orally 1 g of corn/soybean oil (50%/50%), administered orally

Dietary Supplement:
• Arachidonic acid (ARA)
ARA (40% of total fatty acid)
• PZQ+ARA
A single dose of PZQ administered seven days in advance of initial treatment with ARA.

Locations

Country	Name	City	State
Egypt	Tropical Health Department, High Institute of Public Health, Alexandria University	Alexandria
Egypt	Cairo University	Cairo
Egypt	National Liver Institute, Menoufiya University,	Shebin El-Kom	Menoufiya

Sponsors (4)

Lead Sponsor	Collaborator
DSM Nutritional Products, Inc.	Cairo University, High Institute of Public Health, Egypt, National Liver Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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.	No