Modified ORS Solution for Severely Malnourished Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01821586|
Recruitment Status : Completed
First Posted : April 1, 2013
Last Update Posted : December 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Malnourished Children With Watery Diarrhoea||Other: Modified ORS-1 Other: Modified ORS-2 (ReSoMal) Other: Modified ORS-3 (Benefibre)||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||189 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Optimisation of Oral Rehydration Solution and Evaluation of the Efficacy of Benefiber(Partially Hydrolyzed Guar Gum) Containing Modified Oral Rehydration Solution in the Treatment of Severely Malnourished Children With Watery Diarrhoea|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
Experimental: Modified ORS-1
Modified ORS -1 will be assigned to the enrolled particfipants according to the randomization schedule.
Other: Modified ORS-1
Experimental: Modified ORS-2 (ReSoMal)
Modified ORS -2 (ReSoMal) will be assigned to the enrolled particfipants according to the randomization schedule.
Other: Modified ORS-2 (ReSoMal)
Experimental: Modified ORS-3 (Benefibre)
Modified ORS -3 (Benefibre) will be assigned to the enrolled particfipants according to the randomization schedule.
Other: Modified ORS-3 (Benefibre)
- Stool weight [ Time Frame: up to 72 hours ]Collection of stool in cholera cot and measured every 6 hours with a using a electronic scale
- Duration of Diarrhoea [ Time Frame: up to 72 hours ]Time from the onset of randomization upto the stopage of diarrhoea
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): NCT01821586
|Dhaka Hospital, icddr,b|
|Dhaka, Bangladesh, 1212|