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New Hypo-Osmolar ORS (Recommended by WHO) for Routine Use in the Diarrhea Management– Surveillance Study for Adverse Effects

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ClinicalTrials.gov Identifier: NCT00490932
Recruitment Status : Completed
First Posted : June 25, 2007
Last Update Posted : June 25, 2007
Sponsor:
Information provided by:
Society for Applied Studies

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.


Condition or disease Intervention/treatment Phase
Diarrhea Dysentery Drug: Hypo-osmolar ORS Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27966 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Introduction of New Hypo-Osmolar ORS (Recommended by WHO) for Routine Use in the Management of Diarrhoeal Diseases – A Phase IV Surveillance Study
Study Start Date : March 2005
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources




Primary Outcome Measures :
  1. Symptomatic hyponatraemia with clinical features like convulsion or drowsiness or coma.

Secondary Outcome Measures :
  1. Unanticipated adverse effect associated with the routine use of hypo-osmolar ORS solution on a large scale


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490932


Locations
India
ID & BG Hospital, Beliaghata, Kolkata-700 010
Kolkata, West Bengal, India, 700010
Sponsors and Collaborators
Society for Applied Studies
Investigators
Principal Investigator: Dr. Dilip Mahalanabis, MBBS Reviewed and approved by the Ethics Review Committee of the Society for Applied Studies (FWA 00001757)

ClinicalTrials.gov Identifier: NCT00490932     History of Changes
Other Study ID Numbers: ID04001
First Posted: June 25, 2007    Key Record Dates
Last Update Posted: June 25, 2007
Last Verified: February 2007

Keywords provided by Society for Applied Studies:
Watery diarrhea
Bloody diarrhea

Additional relevant MeSH terms:
Diarrhea
Dysentery
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases