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. Identifier: NCT01821586
Recruitment Status : Completed
First Posted : April 1, 2013
Last Update Posted : December 21, 2016
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

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 diarrhoeal stools, and they also are unable to handle excessive salts and water load. Some times they are found to be hyponatraemic due to the shift of sodium inside the cells (inefficient Na+ /K+ pump), and fluids containing higher amounts of sodium (such as the standard ORS) may lead to further increase in the intracellular sodium, fluid overload and heart failure. They also have depleted in potassium stores in the body. Recently, the WHO recommended a special ORS formulation, known as ReSoMal, for management of diarrhoea in severely malnourished children that contains a lower amount of sodium (45mmol/L) and higher amount of potassium (40 mmol/L) than the standard WHO-ORS. It is felt that an ORS containing lower sodium and higher potassium concentration may be useful in correcting hypokalemia, and in lowering the risks of excess sodium and /or overhydration, in severely malnourished children with diarrhoea. The safety of ReSoMaL is, however, still in question due to the risk of hyponatraemia, including symptomatic hyponatraemia, especially in the treatment of severe watery diarrhoea due to Vibrio cholerae and ETEC where loss of sodium in the stool exceeds than that is contained in ReSoMal. Thus an ORS solution with modest concentration of sodium (75 mmol/L) and higher concentration of potassium (40 mmol/L) have been suggested for the treatment of diarrhoea in these children. To improve the efficacy of oral rehydration, in terms of reducing the severity of purging and diarrhoea duration, different approaches (changing the substrates/ reducing the sodium and glucose concentration and osmolarity) have been tried with limited success. Benefiber (partially hydrolysed guar gum), a soluble fiber if added to a ORS solution is expected to be fermented in the colon liberating short chain fatty acids (SCFAs). SCFAs stimulate sodium and water absorption from the colon, and they have trophic effect, act as a fuel source for the colonocytes, have antibacterial properties and stimulates the production commensal flora, thereby may enhance recovery from acute diarrhoea in severely malnourished children. The aims of our proposed study are to examine whether an ORS solution with a modest concentration of sodium will prevent the occurrence of hyponatraemia including symptomatic hyponatraemia, and also whether addition of benefiber will improve the efficacy of ORS solution. This will be a randomized, double blind, controlled clinical trial in 186 children with severe malnutrition and watery diarrhoea (62 in each of the three treatment groups) to compare the efficacy of (i) the currently recommended ORS with some modofication(Na+ 75 mmol/L and K40 momol/L and minerals-Zinc, copper and magnesium), (ii) ReSoMal (Na+ 45 mmol/L), (iii) Currently recommended ORS (Na+ 75 mmol/L, K 40 momol/L and added minerals) with added Benefiber (25 grams/L), in the treatment of acute watery diarrhoea in children with severe malnutrition

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Duration of Diarrhoea [ Time Frame: up to 72 hours ]
    Time from the onset of randomization upto the stopage of diarrhoea

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

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 identifier (NCT number): NCT01821586

Dhaka Hospital, icddr,b
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
University Hospital, Basel, Switzerland

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh Identifier: NCT01821586     History of Changes
Other Study ID Numbers: 2006-005
First Posted: April 1, 2013    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: January 2006

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Severe malnutrition;
modified ORS

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Nutrition Disorders