New Hypo-Osmolar ORS (Recommended by WHO) for Routine Use in the Diarrhea Management– Surveillance Study for Adverse Effects
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.
|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|
- Symptomatic hyponatraemia with clinical features like convulsion or drowsiness or coma.
- Unanticipated adverse effect associated with the routine use of hypo-osmolar ORS solution on a large scale
|Study Start Date:||March 2005|
|Study Completion Date:||April 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490932
|ID & BG Hospital, Beliaghata, Kolkata-700 010|
|Kolkata, West Bengal, India, 700010|
|Principal Investigator:||Dr. Dilip Mahalanabis, MBBS||Reviewed and approved by the Ethics Review Committee of the Society for Applied Studies (FWA 00001757)|