Zinc and copper supplementation in the treatment of acute diarrhoea in children: A randomised controlled trial

Dr Michael Dibley, Associate Professor Archana Patel

During 2002 funding was received from the Wellcome Trust for a randomised controlled trial to be conducted at the Indira Medical College and Daga Memorial Hospital, Nagpur, India. Chief Investigators for this project are Dr Michael Dibley and Associate Professor Archana Patel. The trial will assess the benefits of adding zinc and copper supplements when given with standard treatment to children hospitalised for acute diarrhoea, starting with admission and continuing for 2 weeks, on diarrhoeal duration, severity and complications, including after discharge.

The primary hypothesis of the study is that the supplemented children will experience a 15% reduction in the mean duration of diarrhoea following admission to hospital, a 50% reduction in the proportion of children with acute diarrhoea lasting more than seven days from onset and a 25% reduction in the stool output.

785 children aged 6 to 59 months of age, living within a 30 km radius of Nagpur will be recruited for the trial. It is estimated that this will take 2 years. The treatment groups will be 1) zinc alone, 2) zinc and copper and 3) placebo with each of these treatment groups divided in two sub-groups based on frequency of dose. Each treatment will be administered either once a day or 6 hourly during hospitalisation, and the allocation ratio across all the 6 groups will be uniform. After discharge, the supplements will only be administered as a single daily dose to all children. The dose of zinc will be 2mg/kg bodyweight/day and that of copper will be 0.2mg/kg body weight/day.

Baseline data will be collected at enrolment (eg venous blood sample, history, feeding status), data (eg duration of diarrhoea, total stool output, weight changes) collected for the duration of the hospital visit, and follow-up data every two weeks for three months after discharge. A venous blood sample will also be collected two weeks post-treatment.

The trial will be conducted over a three year period.