Study of zinc and copper supplementation in treatment of children suffering from diarrhoea

Completed

• Conditions: Acute diarrhoea; Digestive System

• Registration Number: ISRCTN85071383
• Lead Sponsor: niversity of Newcastle (Australia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-24
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 808

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-hospital:<br>1. Mean duration of diarrhoea of 3.9 days, measured every day for two weeks<br>2. Duration of diarrhoea (mean duration greater than 7 days from onset of episode), measured every day for two weeks<br>3. Time/rate of rehydration, measured every day for two weeks<br>4. Total stool output (weight), measured every day for two weeks<br>5. Amount of Oral Rehydration Solution (ORS) used, measured every day for two weeks<br>6. Amount of Intravenous (IV) fluids used, measured every day for two weeks<br>7. Weight change: on admission, after 4 hours and then every 24 hours

Secondary Outcome Measures

Name	Time	Method
In-hospital:<br>1. Cost of supplements versus standard treatment<br>2. Rates of complications (measured every day for two weeks): <br>2.1. Electrolyte imbalance<br>2.2. Haemolytic uraemic syndrome<br>2.3. Septicemia<br>2.4. Death<br>3. Differential effects depending on clinical indicators: <br>3.1. Initial zinc status, measured once at baseline and on 14th day<br>3.2. Age, measured every fortnight over a 3 month period following discharge <br>3.3. Breastfeeding status, measured every fortnight over a 3 month period following discharge <br>3.4. Anthropometric indicators, measured every fortnight over a 3 month period following discharge