Antioxidant Supplements in the Reversal of Schistosomal Peri-portal Fibrosis

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.

Conditions

• Schistosomiasis
• Liver Fibrosis
• Periportal Fibrosis
• Oxidative Stress

Interventions

DIETARY_SUPPLEMENT

Praziquantel+antioxidant suppl

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 demonestrable S. mansoni eggs on the subsequent six-monthly evaluations. In addition subjects will receive antioxidant supplement on daily basis for a period of one year.

OTHER

Praziquantel + placebo 2mths then antioxidant for 10 mths

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 demonestrable S. mansoni eggs on the subsequent six-monthly evaluations. In addition subjects will receive placebo as a supplement for two months which will be followed by antioxidant as a supplement for the rest of the year.

DIETARY_SUPPLEMENT

Praziquantel therapy and placebo as supplement

Praziquantel at day 0, 6-weeks and at 12 weeks from start of study. Thereafter praziquantel therapy will be offered if subjects have demonestrable s.mansoni eggs on six-monthly evaluation periods. Placebo will be given as a supplement for one year.

DIETARY_SUPPLEMENT

Praziquantel+antioxidant

Praziquantel treatment will be offered at time 0, six weeks and 12 weeks from the start. Antioxidant supplement will be offered on a daily basis for a period of one year

Sponsors & Collaborators

• Ullevaal University Hospital

  collaborator OTHER

• University of Oslo

  collaborator OTHER

• University of Agder

  collaborator OTHER

• Sorlandet Hospital HF

  collaborator OTHER_GOV

• Addis Ababa University

  lead OTHER

Principal Investigators

• Nega Berhe, MD, PhD · Aklilu Lemma Institute of Pathobiology, Addis Ababa University

• Svein G Gundersen, MD PhD · Sorlandet Hospital HF, Box 416, 4604 Kristiansand - Norway

• Bjørn Myrvang, MD, PhD · Ullevål University Hospital, Department of Infectious Diseases, Centre for Imported and Tropical Diseases, 0407 Oslo

• Rune Blomhoff, MSc, PhD · Institute for Basic Medical Sciences, Department of Nutrition, University of Oslo, P.O.box 1046, N-0316 Oslo, Norway

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

SINGLE_GROUP

Eligibility

Min Age

5 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2013-06-30

Completion

2015-12-31

Countries

• Ethiopia

Study Locations