Extrait

Background and study aims Diarrhoea causes an estimated 2.5 million child deaths in developing countries each year, 35% of which are due to acute diarrhoea. Zinc and copper stores in the body are known to be depleted during acute diarrhoea. Our objectives were to evaluate the efficacy of zinc and copper supplementation when given with standard treatment to children with acute watery or bloody diarrhoea. Who can participate? Inclusion Criteria 1. Children with Six to 60 months of age, either sex 2. Presence of diarrhoea 3. Duration of diarrhoea ≤ 72 hours prior to admission 4. Ability to take oral feeds or breast feeds 5. Caretaker willing to sign informed consent Exclusion criteria 1. Serious complicating illness/disease 2. Clinically apparent kwashiorkor (malnutrition) 3. Residence more than 30 km from Nagpur 4. Previously enrolled in this trial What does the study involve? The treatment groups were: 1. Zinc alone 2. Zinc and copper 3. Placebo with each of these treatment groups divided in two sub-groups based on frequency of dose Each treatment was administered either once a day or 6 hourly during hospitalisation and the allocation ratio across all the six groups was uniform. After discharge, the supplements were only administered as a single daily dose to all children. These doses of supplements were administered for a total duration of two weeks from enrolment in the trial including after discharge from hospital. What are the possible benefits and risks of participating? There are no known side effects from taking zinc and copper supplements in the amounts that will be given to your child during this study. It is possible that these supplements will hasten your child’s recovery from diarrhoea and prevent further illnesses following discharge from hospital. Two additional blood collections will be required and these may cause some pain and distress to your child. To minimize this discomfort we will use a cream on the skin to reduce any pain. Where is the study run from? Indira Gandhi Government Medical College, Nagpur, India When is the study starting and how long is it expected to run for? The study started in September 2003 and ended in October 2006. Who is funding the study? The Welcome Trust (UK) Who is the main contact? Dr. Archana B. Patel [email protected] [email protected]

Critère d'inclusion

• Acute diarrhoea

Liens

• ictrp
• isrctn