Clinical Trial: Arachidonic Acid Treatment Against Schistosomiasis Infection in Children
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effects of Arachidonic Acid Supplementation on Schistosomiasis Mansoni Infection in Egyptian School Children
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 Summary:
Sponsor: DSM Nutritional Products, Inc.
Current Primary Outcome: Percent egg reduction [ Time Frame: 4 weeks after end of 1 day PZQ treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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.
Original Secondary Outcome: Same as current
Information By: DSM Nutritional Products, Inc.
Dates:
Date Received: May 16, 2014
Date Started: January 2013
Date Completion:
Last Updated: May 19, 2014
Last Verified: May 2014