Status:

COMPLETED

Modified ORS Solution for Severely Malnourished Children

Lead Sponsor:

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborating Sponsors:

University Hospital, Basel, Switzerland

Conditions:

Malnourished Children With Watery Diarrhoea

Eligibility:

All Genders

6-36 years

Phase:

PHASE2

Brief Summary

Diarrhoea and malnutrition are the common childhood illnesses responsible for higher deaths in developing counties. Physiologically, malnourished children excrete lower amounts of salts and water in d...

Detailed Description

Study Design This will be a randomized, double-blind, controlled clinical trial to assess the efficacy of three different modified ORSs: (i) Currently recommended ORS with some modification (Na+ 75, K...

Eligibility Criteria

Inclusion

  • Some or severe dehydration (assessed by WHO Guidelines).
  • Weight for height (W/H) \<70% of NCHS median or with bipedal edema.
  • Written informed consent from parents/ guardians

Exclusion

  • Blood or mucus in stools
  • Have received antidiarhoeal drugs for their diarrhoea
  • Severe diseases (e.g. severe pneumonia with respiratory distress, clinical sepsis, meningitis) requiring intensive care and other ancillary support like O2 inhalation, oropharyngeal suction etc.

Key Trial Info

Start Date :

April 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2009

Estimated Enrollment :

189 Patients enrolled

Trial Details

Trial ID

NCT01821586

Start Date

April 1 2006

End Date

July 1 2009

Last Update

December 21 2016

Active Locations (1)

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Dhaka Hospital, icddr,b

Dhaka, Bangladesh, 1212