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

Zinc and copper supplementation in treatment of acute diarrhoea in children: a randomised controlled clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN85071383

Enrollment

808

Registered

2007-09-24

Start date

2003-09-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute diarrhoea Digestive System Acute diarrhoea

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 eithe

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026