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 ]

Stool samples were collected from each child on three consecutive days to determine egg counts per gram of stool.


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