Antioxidant Supplements in the Reversal of Schistosomal Peri-portal Fibrosis

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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