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

This study has been completed.
Sponsor:
Information provided by:
Society for Applied Studies
ClinicalTrials.gov Identifier:
NCT00490932
First received: June 22, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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 Intervention Phase
Diarrhea
Dysentery
Drug: Hypo-osmolar ORS
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Society for Applied Studies:

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

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

Enrollment: 27966
Study Start Date: March 2005
Study Completion Date: April 2007
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00490932     History of Changes
Other Study ID Numbers: ID04001
Study First Received: June 22, 2007
Last Updated: June 22, 2007
Health Authority: India: Ministry of Health

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

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 22, 2014