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Study of zinc and copper supplementation in treatment of children suffering from diarrhoea
ISRCTN ISRCTN85071383
DOI 10.1186/ISRCTN85071383
ClinicalTrials.gov identifier
EudraCT number
Public title Study of zinc and copper supplementation in treatment of children suffering from diarrhoea
Scientific title Zinc and copper supplementation in treatment of acute diarrhoea in children: a randomised controlled clinical trial
Acronym CDP
Serial number at source GR068664AIA
Study hypothesis In a randomised controlled trial of supplementation for 2 weeks of 2 mg/kg/day of zinc or 2 mg/kg/day of zinc and 0.2 mg/kg/day of copper together with standard treatment, given to children hospitalised for acute diarrhoea, the children supplemented with zinc alone in comparison to the placebo group, or the children supplemented with zinc and copper in comparison to placebo group will at least experience the following.

Primary hypotheses:
1. 15% reduction in the mean duration of diarrhoea following admission to hospital
2. 50% reduction in the proportion of children with acute diarrhoea lasting more than seven days from onset
3. 25% reduction in the total stool output weight

Secondary hypotheses:
4. 30% increase in the proportion of children who are successfully rehydrated with oral rehydration solution
5. Increasing the frequency of dosage will increase the beneficial impact of zinc and copper supplementation on the clinical outcomes of acute diarrhoeal disease
6. 20% reduction in predicted mean total cost of treating patients with acute diarrhoea in the zinc and copper supplemented study groups as compared to the placebo group from the patient and providerís perspective

Tertiary hypotheses:
7. 50% reduction in the proportion of children with acute diarrhoea who experience any the following complications:
7.1. Haemolytic uraemia syndrome
7.2. Septicaemia
7.3. Death
8. The effect of zinc and copper supplementation on each specific clinical indicator is different depending on the initial zinc status, initial anthropometric status, age and breastfeeding status
Lay summary 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 childís 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
dr_apatel@yahoo.com
ceuiggmc@yahoo.co.in
Ethics approval Ethics approval received from:
1. Indira Gandhi Government Medical College (IGGMC) on the 18th January 2003 (ref: 19/8/10/02)
2. University of Newcastle Ethics Committee (ref: H-500-0203)
Study design Randomised, double blind, placebo controlled clinical trial
Countries of recruitment India
Disease/condition/study domain Acute diarrhoea
Participants - inclusion criteria 1. Six to 60 months of age, either sex
2. Presence of diarrhoea
3. Duration of diarrhoea less then or equal to 72 hours prior to admission
4. Ability to take oral feeds or breast feeds
5. Caretaker willing to sign informed consent
Participants - exclusion criteria 1. Serious complicating illness/disease
2. Clinically apparent kwashiorkor
3. Residence more than 30 km from Nagpur
4. Previously enrolled in this trial
Anticipated start date 01/09/2003
Anticipated end date 30/10/2006
Status of trial Completed
Patient information material
Target number of participants 808
Interventions 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. The dose of zinc was 2 mg/kg body weight/day and that of copper was 0.2 mg/kg body weight/day. These doses of supplements were administered for a total duration of two weeks from enrolment in the trial including after discharge from hospital.
Primary outcome measure(s) In-hospital:
1. Mean duration of diarrhoea of 3.9 days, measured every day for two weeks
2. Duration of diarrhoea (mean duration greater than 7 days from onset of episode), measured every day for two weeks
3. Time/rate of rehydration, measured every day for two weeks
4. Total stool output (weight), measured every day for two weeks
5. Amount of Oral Rehydration Solution (ORS) used, measured every day for two weeks
6. Amount of Intravenous (IV) fluids used, measured every day for two weeks
7. Weight change: on admission, after 4 hours and then every 24 hours
Secondary outcome measure(s) In-hospital:
1. Cost of supplements versus standard treatment
2. Rates of complications (measured every day for two weeks):
2.1. Electrolyte imbalance
2.2. Haemolytic uraemic syndrome
2.3. Septicemia
2.4. Death
3. Differential effects depending on clinical indicators:
3.1. Initial zinc status, measured once at baseline and on 14th day
3.2. Age, measured every fortnight over a 3 month period following discharge
3.3. Breastfeeding status, measured every fortnight over a 3 month period following discharge
3.4. Anthropometric indicators, measured every fortnight over a 3 month period following discharge
Sources of funding The Wellcome Trust (UK) (grant ref: 068664)
Trial website
Publications 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23177894
Contact name Dr  Archana  Patel
  Address 125, Katol Road
Opp. Tidke Vidyalaya
Nagpur - 18
  City/town Nagpur
  Zip/Postcode 440013
  Country India
  Email dr_apatel@yahoo.com
Sponsor University of Newcastle (Australia)
  Address c/o Dr Michael J. Dibley
Senior Lecturer in Epidemiology
Centre for Clinical Epidemiology & Biostatistics
Faculty of Health
Upper Level - Bowman Building
University Drive
  City/town Callaghan
  Zip/Postcode NSW 2308
  Country Australia
  Sponsor website: http://www.newcastle.edu.au/
Date applied 31/08/2007
Last edited 09/05/2013
Date ISRCTN assigned 24/09/2007
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