NCT00278746

Brief Summary

Several studies have shown the beneficial effect of zinc treatment in acute diarrhea. There was a significant reduction in duration of the treated episodes and in their severity as measured by diarrheal stool output or frequency. Zinc is a potentially important immunomodulator or nutraceutical which may have great impact as therapeutic agent in conditions like diarrhea and pneumonia. The issue is whether and how zinc should be introduced in primary health care programs for treatment of acute diarrhea. A practical, sustainable intervention for introduction of zinc as treatment of acute diarrhoea in national programs is therefore required. This study aimed to address this issue.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,032

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 13, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

June 16, 2015

Status Verified

June 1, 2015

Enrollment Period

1.7 years

First QC Date

January 13, 2006

Last Update Submit

June 15, 2015

Conditions

DiarrheaMortalityHospitalization

Keywords

zincdiarrheacluster randomizationhospitalization

Outcome Measures

Primary Outcomes (4)

  • To evaluate in a community based controlled effectiveness trial whether addition of zinc as a therapeutic modality for diarrhea delivered through existing channels, including at village level to the current case management package for under-five children

    20 months (Jan 2005 to Sep 2006)

  • - Reduction in visits to health care providers for treatment of illness

    20 months (Jan 2005 to Sep 2006)

  • - Reduction in drug use; antibiotics and other drugs during diarrheal illnesses

    20 months (Jan 2005 to Sep 2006)

  • - Increase in ORS use during diarrhea in the intervention communities.

    20 months (Jan 2005 to Sep 2006)

Secondary Outcomes (1)

  • - Reduction in all cause hospitalizations

    20 months (Jan 2005 to Sep 2006)

Study Arms (2)

1

EXPERIMENTAL

Zinc and ORS were promoted for treatment of diarrhea in underfive children

Drug: Zinc and ORS

2

OTHER

Promoted routine management of diarrhea in underfive with ORS

Drug: ORS only

Interventions

Zinc and ORSDRUG

Government and private providers and village health workers were trained to prescribe zinc and ORS for use in diarrheal episodes in 1 month to 5 years old children in intervention communities

1
ORS onlyDRUG

Promoted routine management of diarrhea in underfive with ORS

2

Eligibility Criteria

Age1 Month - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 1 month to 5 years with diarrhea

You may not qualify if:

  • Illness requiring referral to hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Society for Applied Studies

New Delhi, National Capital Territory of Delhi, 110017, India

Location

Related Publications (1)

  • Bhandari N, Mazumder S, Taneja S, Dube B, Agarwal RC, Mahalanabis D, Fontaine O, Black RE, Bhan MK. Effectiveness of zinc supplementation plus oral rehydration salts compared with oral rehydration salts alone as a treatment for acute diarrhea in a primary care setting: a cluster randomized trial. Pediatrics. 2008 May;121(5):e1279-85. doi: 10.1542/peds.2007-1939.

    PMID: 18450870RESULT

MeSH Terms

Conditions

Diarrhea

Interventions

ZincORALIT

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Nita Bhandari, PhD

    Society for Applied Studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2006

First Posted

January 18, 2006

Study Start

January 1, 2005

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

June 16, 2015

Record last verified: 2015-06

Locations

IN(1)