SchistosomiasisNCT02144389
Arachidonic Acid Treatment Against Schistosomiasis Infection in Children
A study testing Praziquantel (PZQ), Arachidonic acid (ARA) and PZQ+ARA in people with Schistosomiasis and Bilharzia, run by dsm-firmenich Switzerland AG at 3 sites in Egypt.
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… Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Schistosomiasis, Bilharzia
- What is being tested?
- Praziquantel (PZQ), Arachidonic acid (ARA) and PZQ+ARA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 3 sitesEgypt
- Study dates
- Jan 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- consent from parent or legal guardian
- clinically confirmed schistosomiasis
Who cannot join
- not infected with schistosomiasis
- less than 6 or greater than 15 years of age
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Tropical Health Department, High Institute of Public Health, Alexandria University
Alexandria
Cairo University
Cairo
National Liver Institute, Menoufiya University,
Shebin El-Kom, Monufia Governorate
About this study
Official title: Effects of Arachidonic Acid Supplementation on Schistosomiasis Mansoni Infection in Egyptian School Children
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.
- Conditions
- Schistosomiasis, Bilharzia
- Being tested
- Praziquantel (PZQ), Arachidonic acid (ARA), PZQ+ARA
- Keywords
- Arachidonic acid, Bilharzia, Mansoni, Schistosomiasis, Polyunsaturated fatty acid
- Medical subject headings
- Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Praziquantel (PZQ)Drug
Also called Praziquantel (generic), Biltricide, trematodicide
40 mg/kg, a single dose, administered orally
1 g of corn/soybean oil (50%/50%), administered orally
Arachidonic acid (ARA)Dietary supplement
Also called ARASCO, Microbial arachidonic acid-rich oil
ARA (40% of total fatty acid)
PZQ+ARADietary supplement
Also called ARASCO, praziquantel
A single dose of PZQ administered seven days in advance of initial treatment with ARA.
| Study group | Role | What they receive |
|---|---|---|
| Praziquantel (PZQ) | Active comparator | 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. Receives: Drug: Praziquantel (PZQ) |
| Arachidonic acid (ARA) | Experimental | A single daily dose of 1 g microbial arachidonic acid-rich oil administered orally for 15 consecutive days of school. Receives: Dietary Supplement: Arachidonic acid (ARA) |
| PZQ + ARA | Experimental | 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. Receives: Dietary Supplement: PZQ+ARA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent egg reduction
Stool samples were collected from each child on three consecutive days to determine egg counts per gram of stool.
Measured: 4 weeks after end of 1 day PZQ treatment
Secondary outcomes (2)
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.
Measured: Three days after a 15-day ARA supplementation
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.
Measured: Three days after 15-day ARA supplementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startJan 2013
- Primary completionJul 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchistosomiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Liver Institute, Egypt, Cairo University, High Institute of Public Health, Egypt
- Responsible party
- Sponsor
- Investigators
- Rashika El Ridi, Principal investigator, Cairo UniversitySahar Selim, Ph.D., Study director, National Liver Institute, Menoufiya UniversityRashida Barakat, Ph.D., Study director, High Institute of Public Health, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144389
- Sponsor's protocol ID
- 2012-1054
- Status last verified
- May 2014
- First submitted
- 16 May 2014
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Barakat R, Abou El-Ela NE, Sharaf S, El Sagheer O, Selim S, Tallima H, Bruins MJ, Hadley KB, El Ridi R. Efficacy and safety of arachidonic acid for treatment of school-age children in Schistosoma mansoni high-endemicity regions. Am J Trop Med Hyg. 2015 Apr;92(4):797-804. doi: 10.4269/ajtmh.14-0675. Epub 2015 Jan 26.
PubMed 25624403
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Arachidonic Acid Supplementation on Schistosomiasis Mansoni Infection in Egyptian School Children
- ClinicalTrials.gov ID
- NCT02144389
- Acronym / sponsor ID
- 2012-1054
- Conditions
- Schistosomiasis, Bilharzia
- Keywords
- Arachidonic acid, Bilharzia, Mansoni, Schistosomiasis, Polyunsaturated fatty acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Collaborators
- National Liver Institute, Egypt, Cairo University, High Institute of Public Health, Egypt
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 22 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Praziquantel (PZQ) | Active comparator | Drug: 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. |
| Arachidonic acid (ARA) | Experimental | Dietary Supplement: Arachidonic acid (ARA)A single daily dose of 1 g microbial arachidonic acid-rich oil administered orally for 15 consecutive days of school. |
| PZQ + ARA | Experimental | Dietary Supplement: PZQ+ARAA 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. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- consent from parent or legal guardian
- clinically confirmed schistosomiasis
Key exclusion criteria (2 listed)
- not infected with schistosomiasis
- less than 6 or greater than 15 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Praziquantel (PZQ)Also: Praziquantel (generic), Biltricide, trematodicide40 mg/kg, a single dose, administered orally 1 g of corn/soybean oil (50%/50%), administered orally | Drug | Praziquantel (PZQ) |
| Arachidonic acid (ARA)Also: ARASCO, Microbial arachidonic acid-rich oilARA (40% of total fatty acid) | Dietary supplement | Arachidonic acid (ARA) |
| PZQ+ARAAlso: ARASCO, praziquantelA single dose of PZQ administered seven days in advance of initial treatment with ARA. | Dietary supplement | PZQ + ARA |
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.
2 secondary outcomes
Biochemical and hematological parameters
Time frame: Three days after a 15-day ARA supplementation
Total plasma phospholipids
Time frame: Three days after 15-day ARA supplementation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
- Derived from this study: PubMed 25624403Barakat R, Abou El-Ela NE, Sharaf S, El Sagheer O, Selim S, Tallima H, Bruins MJ, Hadley KB, El Ridi R. Efficacy and safety of arachidonic acid for treatment of school-age children in Schistosoma mansoni high-endemicity regions. Am J Trop Med Hyg. 2015 Apr;92(4):797-804. doi: 10.4269/ajtmh.14-0675. Epub 2015 Jan 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rashika El Ridi principal investigator
Cairo University
Sahar Selim, Ph.D. study director
National Liver Institute, Menoufiya University
Rashida Barakat, Ph.D. study director
High Institute of Public Health, Alexandria University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Praziquantel (PZQ), Arachidonic acid (ARA) and PZQ+ARA in people with Schistosomiasis and Bilharzia, run by dsm-firmenich Switzerland AG at 3 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent egg reduction (time frame: 4 weeks after end of 1 day PZQ treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02144389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2014.