Arachidonic Acid Treatment Against Schistosomiasis Infection in Children

DSM Nutritional Products

Status: Completed

Conditions: Schistosomiasis; Bilharzia

Treatments: Dietary Supplement: PZQ+ARA; Drug: Praziquantel (PZQ); Dietary Supplement: Arachidonic acid (ARA)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02144389

2012-1054

Details and patient eligibility

About

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.

Enrollment: 335 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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335 participants in 3 patient groups

Praziquantel (PZQ)

Active Comparator group

Description:

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.

Treatment:

Drug: Praziquantel (PZQ)

Arachidonic acid (ARA)

Experimental group

Description:

A single daily dose of 1 g microbial arachidonic acid-rich oil administered orally for 15 consecutive days of school.

Treatment:

Dietary Supplement: Arachidonic acid (ARA)

PZQ + ARA

Experimental group

Description:

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.

Treatment:

Dietary Supplement: PZQ+ARA