Arachidonic Acid Treatment Against Schistosomiasis Infection in Children

Not Applicable

Completed

• Conditions: Schistosomiasis; Bilharzia
• Interventions: Dietary Supplement: PZQ+ARA; Dietary Supplement: Arachidonic acid (ARA); Drug: Praziquantel (PZQ)

• Registration Number: NCT02144389
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-07
• Study Completion: 2014-01
• Status Verified: 2014-05
• Study First Submitted: 2014-05-16
• Study First Submitted QC: 2014-05-19
• Last Update Submitted: 2014-05-19
• Study First Posted: 2014-05-22
• Last Update Posted: 2014-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 335

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PZQ + ARA	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.
Arachidonic acid (ARA)	Arachidonic acid (ARA)	A single daily dose of 1 g microbial arachidonic acid-rich oil administered orally for 15 consecutive days of school.
Praziquantel (PZQ)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (3)

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, Egypt