NCT00490932

Brief Summary

For more than 25 years WHO and UNICEF have recommended a single formulation of glucose-based Oral Rehydration Salts (ORS) to prevent or treat dehydration from diarrhoea irrespective of the cause or age group affected. This product has proven effective and contributed substantially to the dramatic global reduction in mortality from diarrhoeal disease during the period. Based on more than two decades of research and recommendations by an expert group, WHO and UNICEF reviewed the effectiveness of a new ORS formula with reduced concentration of glucose and salts. Because of the improved effectiveness of this new ORS solution WHO and UNICEF recommended that countries use and manufacture this new formulation in place of the old one. While recommending this new ORS the experts also recommended that further monitoring is desirable to better assess the risk, if any of symptomatic hyponatraemia (low blood level of sodium salt). This is a surveillance study to evaluate adverse effect of routinely using the new ORS in a hospital admitting over 20,000 patients with diarrhea of all ages including cholera. If the new ORS is found safe, it will provide added confidence in its global use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27,966

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2005

Typical duration for phase_4

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

March 1, 2005

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2007

Completed
Last Updated

June 25, 2007

Status Verified

February 1, 2007

First QC Date

June 22, 2007

Last Update Submit

June 22, 2007

Conditions

DiarrheaDysentery

Keywords

Watery diarrheaBloody diarrhea

Outcome Measures

Primary Outcomes (1)

  • Symptomatic hyponatraemia with clinical features like convulsion or drowsiness or coma.

Secondary Outcomes (1)

  • Unanticipated adverse effect associated with the routine use of hypo-osmolar ORS solution on a large scale

Interventions

Hypo-osmolar ORSDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients admitted with diarrhoea over the study period of 12 months will be eligible for the study, which include men, women and children.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ID & BG Hospital, Beliaghata, Kolkata-700 010

Kolkata, West Bengal, 700010, India

Location

MeSH Terms

Conditions

DiarrheaDysentery

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Dr. Dilip Mahalanabis, MBBS

    Reviewed and approved by the Ethics Review Committee of the Society for Applied Studies (FWA 00001757)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 22, 2007

First Posted

June 25, 2007

Study Start

March 1, 2005

Study Completion

April 1, 2007

Last Updated

June 25, 2007

Record last verified: 2007-02

Locations

IN(1)