Modified ORS Solution for Severely Malnourished Children

This study has been completed.
Sponsor:
Collaborator:
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01821586
First received: March 27, 2013
Last updated: March 29, 2013
Last verified: January 2006
  Purpose

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 Intervention Phase
Malnourished Children With Watery Diarrhoea
Other: Modified ORS-1
Other: Modified ORS-2 (ReSoMal)
Other: Modified ORS-3 (Benefibre)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Stool weight [ Time Frame: up to 72 hours ] [ Designated as safety issue: Yes ]
    Collection of stool in cholera cot and measured every 6 hours with a using a electronic scale


Secondary Outcome Measures:
  • Duration of Diarrhoea [ Time Frame: up to 72 hours ] [ Designated as safety issue: Yes ]
    Time from the onset of randomization upto the stopage of diarrhoea


Enrollment: 189
Study Start Date: April 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01821586

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

No publications provided

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01821586     History of Changes
Other Study ID Numbers: PR-200-005
Study First Received: March 27, 2013
Last Updated: March 29, 2013
Health Authority: Bangladesh: Ethical Review Committee

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

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

ClinicalTrials.gov processed this record on July 29, 2014