Brief Title
Antioxidant Supplements in the Reversal of Schistosomal Peri-portal Fibrosis
Official Title
Study on the Role of Antioxidant Micronutrients on the Reversal of Schistosomal Peri-portal Fibrosis of the Liver.
Brief Summary
Liver fibrosis is the most serious complication of schistosomiasis mansoni. However only limited proportion of subjects with infection develop this pathology and there is limited knowledge on risk factors for the differential morbidity patterns observed in endemic communities. Our preliminary cross-sectional study indicated that serum levels of antioxidants may be related with the development of fibrosis. The present project is a randomised double blinded placebo controlled prospective study investigating the role of food based antioxidant supplements on the outcome of anti-schistosomal chemotherapy with regards to the extent of fibrosis reversal.
Detailed Description
Schistosomiasis is the second leading parasitic disease worldwide, after malaria. Liver fibrosis is the most serious complication of schistosomiasis mansoni which can lead to reduced work capacity and early death in endemic countries. There is, however, limited knowledge on the development of liver fibrosis and the differential patterns morbidity observed in endemic communities. Our preliminary cross-sectional study in Ethiopia seems to indicate that serum levels of antioxidants may influence the development of fibrosis. The present project is a translational study combining basic antioxidant laboratory work with is a randomised double blinded placebo controlled prospective study in endemic areas in Ethiopia, investigating the role of food based antioxidant supplements on the outcome of anti-schistosomal chemotherapy with regards to the extent of fibrosis reversal. In addition, analysis of dietary intakes of antioxidants among communities with comparable levels of S. mansoni infection but with differing levels of schistosomal periportal fibrosis will be undertaken to compare serum levels of antioxidants and prevalence of liver fibrosis. Furthermore we plan to assess development of schistosomal peri-portal fibrosis in a cohort of students established 9 years back who had comparable levels of community prevalence of schistosomiasis but with differing access to fruits and vegetables. Research on this topic has a high priority globally which is in line with the millennium development goals. Knowledge in this field will also add to our understanding of fibrosis development in general and to the efficacy of clinical treatment of schistosomiasis in particular.
Study Type
Interventional
Primary Outcome
Effect of antioxidant supplement on fibrosis reversal following praziquantel therapy
Secondary Outcome
Time required for the reversal of schistosomal periportal fibrosis
Condition
Schistosomiasis
Intervention
Praziquantel+antioxidant suppl
Study Arms / Comparison Groups
praziquantel+antioxidant
Description: Praziquantel therapy will be offered at the start, at six weeks and at 12 weeks from date of enrollment. Thereafter praziquantel therapy will be offered if subjects have demonstrable S. mansoni eggs on the subsequent six-monthly evaluations. In additions, antioxidant suppliment will be given daily for a period of one year
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Dietary Supplement
Estimated Enrollment
414
Start Date
January 2010
Completion Date
December 2015
Primary Completion Date
June 2013
Eligibility Criteria
Inclusion Criteria: - Subjects with schistosomal periportal fibrosis will be eligible for the study Exclusion Criteria: - Subjects with acute malaria, tuberculosis or other chronic diseases such as diabetes mellitus, cardiovascular disease or cancer will be excluded from the study.
Gender
All
Ages
5 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Nega Berhe, MD, PhD, 00251-911-408340, [email protected]
Location Countries
Ethiopia
Location Countries
Ethiopia
Administrative Informations
NCT ID
NCT01260012
Organization ID
2010/794-1
Study Sponsor
Addis Ababa University
Collaborators
Ullevaal University Hospital
Study Sponsor
Nega Berhe, MD, PhD, Principal Investigator, Aklilu Lemma Institute of Pathobiology, Addis Ababa University
Verification Date
September 2010