Acute Watery DiarrheaNCT07026682
Comparison of Low Osmolar ORS and ReSoMal for Treating Acute Watery Diarrhea in Severely Malnourished Children Aged 6 Months to 5 Years
A study testing Low Osmolar ORS and ReSoMal in people with Acute Watery Diarrhea and Severe Acute Malnutrition in Childhood, run by University of Child Health Sciences and Children's Hospital, Lahore at 1 site in Pakistan.
Trial summary
Acute watery diarrhea is a common and serious health issue in children, especially in those who are severely malnourished. These children are at a much higher risk of complications such as dehydration, electrolyte imbalances, and even death. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Acute Watery Diarrhea, Severe Acute Malnutrition in Childhood, Dehydration in Children
- What is being tested?
- Low Osmolar ORS and ReSoMal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Feb 2025to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 months to 5 years.
- Both male and female.
- Children presenting with acute watery diarrhea.
- Children have mild to moderate dehydration.
- Children have serum sodium (135-145 mEq/L) and serum Potassium (2.5-3.4 mEq/L).
- Presence of severe malnutrition, defined as weight-for-length ≤ 3 standard deviations from the median of the World Health Organization (WHO) growth standards or mid-upper arm circumference (MUAC) <115 mm.
- Children tolerating oral fluid.
- Parent or guardian willing and able to provide informed consent for participation.
Who cannot join
- Critically ill children with shock, history of not passed urine for 6 h, convulsions and electrolyte abnormality requiring intravenous (IV) for severe dehydration.
- History of chronic gastrointestinal disorders, such as inflammatory bowel disease or celiac disease.
- Received antibiotics within 48 hours before enrollment.
- Children having any systemic illness requiring hospitalization or specific treatment, such as sepsis or pneumonia.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University Of Child Health Sciences, Lahore
Lahore, Punjab Province, 54000
About this study
Official title: Comparison of Efficacy and Side Effect of Low Osmolar Oral Rehydration Solution Versus Oral Rehydration Solution For Malnourished Children (ReSoMal) in Management of Acute Watery Diarrhea in Severe Malnourished Children
Acute watery diarrhea is a common and serious health issue in children, especially in those who are severely malnourished. These children are at a much higher risk of complications such as dehydration, electrolyte imbalances, and even death. Oral Rehydration Solutions (ORS) are a widely used treatment to prevent and correct dehydration in such children. However, there are different types of ORS, and it is still unclear which one is more effective and safer for use in severely malnourished children.
This clinical study is being conducted at The Children's Hospital, Lahore, to compare two different types of ORS: low osmolar ORS and ReSoMal (a special rehydration solution designed for malnourished children). The aim is to determine which solution is more effective in correcting low potassium levels (a common problem in these children) and to identify which one has fewer side effects, particularly problems like low or high sodium levels that can be dangerous.
Read more
A total of 72 children between 6 months and 5 years of age, all diagnosed with severe malnutrition and mild to moderate dehydration due to acute watery diarrhea, will be included in the study. They will be randomly assigned to receive either low osmolar ORS or ReSoMal. Blood tests will be done before and after the treatment to check for changes in electrolyte levels. The frequency of diarrhea and the child's overall response to treatment will also be recorded.
The hypothesis of this study is that there is a significant difference in both effectiveness and side effects between the two ORS solutions. The results of this study will help doctors choose the safest and most effective ORS for treating diarrhea in severely malnourished children, improving care and potentially saving lives.
Read the detailed description
After approval from ethical review committee of the hospital, 72 (36 in each group) severe malnourished children with watery diarrhea who present in the Department of Pediatrics Medicine University of Child Health Sciences,The Children's hospital Lahore will be included. Parents of the children who fulfill the above criteria will be counseled and explained the details of the study. Written informed consent and detailed history will be taken from each patient parent related to duration and frequency diarrhea. They will be divided into the following two groups using lottery method.
Group-I: Low osmolar ORS. (mmol/L: Na+ 75, K+ 20, Cl- 65, citrate 10, glucose 75, and osmolarity 245) Group-II: ReSoMal ORS. (Na 45 mmol/L, K 40 mmol/L, Cl 76 mmol/L, citrate 7 mmol/L, Mg 6 mmol/L, Zn 300 lmol/ L, Cu 45 lmol/L, glucose 125 mmol/L, osmolarity 300 mmol/L) At arrival in the hospital the dehydration status of the children will be assessed using the dehydration severity score (appendix). The weight of each child along with the height will be noted and I/V lines saved under aseptic measure. Base line investigations including the electrolytes and renal function tests will be sent to the lab and appropriate management of the infection with suitable antibiotics will be started. Fluid deficit will be corrected with 10 mL/kg/h of the assigned ORS given over the first 2 hours, then 5 mL/kg/h over a period of 10 to 12 hours until the deficit is corrected. Ongoing stool losses will be corrected with 5mL/kg after each watery or loose stool. The patients in group-I will receive low osmolar ORS fluid while the patients in group-II will receive standard ORS fluid. 24 hours after the fluid therapy started, blood will be drawn and will be sent for the measurement of electrolytes. The efficacy and side effects will be labelled as per operational definition. The frequency of passage of stool in the 24 hours will also be noted.
All data along will the lab values will be recorded into the attached performa, and all the labs will be done from the hospital lab.
- Being tested
- Low Osmolar ORS, ReSoMal
- Keywords
- Low Osmolar Oral Rehydration Solution, ReSoMal, Malnourished Children, Pediatric Diarrhea, Severe Malnutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Osmolar ORSDrug
Composition: Na⁺ 75 mmol/L, K⁺ 20 mmol/L, Cl- 65 mmol/L, citrate 10 mmol/L, glucose 75 mmol/L; osmolarity 245 mmol/L.
Administered orally in rehydration regimen over 24 hours.
ReSoMalDrug
Composition: Na⁺ 45 mmol/L, K⁺ 40 mmol/L, Cl- 76 mmol/L, citrate 7 mmol/L, glucose 125 mmol/L, Mg 6 mmol/L, Zn 300 µmol/L, Cu 45 µmol/L; osmolarity 300 mmol/L.
Administered orally over 24 hours according to rehydration protocol.
| Study group | Role | What they receive |
|---|---|---|
| Group Low Osmolar ORS | Experimental | Received low osmolar oral rehydration solution (ORS) with an osmolarity of 245 mmol/L and sodium 75 mmol/L, administered orally according to WHO guidelines for rehydration in diarrhea. Receives: Drug: Low Osmolar ORS |
| Group ReSoMal | Active comparator | Received ReSoMal oral rehydration solution specifically formulated for malnourished children, with lower sodium and higher potassium content, administered orally. Receives: Drug: ReSoMal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correction of Hypokalemia After 24 Hours of Oral Rehydration
This outcome assesses the proportion of participants whose serum potassium levels normalize after 24 hours of treatment with either low osmolar ORS or ReSoMal. Hypokalemia is defined as serum potassium <3.5 mmol/L. Correction is considered achieved if serum potassium rises to ≥3.5 mmol/L without requiring intravenous potassium supplementation.
Measured: 24 hours after initiation of oral rehydration therapy
Secondary outcomes (1)
Incidence of Hyponatremia and Hypernatremia After 24 Hours of Oral Rehydration
This outcome captures the number of participants who develop electrolyte imbalances, specifically hyponatremia (serum sodium <135 mEq/L) or hypernatremia (serum sodium >145 mEq/L), following 24 hours of rehydration with either low osmolar ORS or ReSoMal.
Measured: 24 hours after initiation of oral rehydration therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start10 Feb 2025
- Primary completion10 Jul 2025 (estimated)
- Study completion10 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Watery DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Child Health Sciences and Children's Hospital, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadaf Sumreen, University of Child Health Sciences and Children's Hospital, Lahore
- Investigators
- Sadaf Sumreen, Principal investigator, University Of Child Health Sciences, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026682
- Sponsor's protocol ID
- UCHSLahore1
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Side Effect of Low Osmolar Oral Rehydration Solution Versus Oral Rehydration Solution For Malnourished Children (ReSoMal) in Management of Acute Watery Diarrhea in Severe Malnourished Children
- ClinicalTrials.gov ID
- NCT07026682
- Acronym / sponsor ID
- UCHSLahore1
- Keywords
- Low Osmolar Oral Rehydration Solution, ReSoMal, Malnourished Children, Pediatric Diarrhea, Severe Malnutrition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Child Health Sciences and Children's Hospital, LahoreUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 10 Jul 2025 (estimated)
- Study completion
- 10 Jul 2025 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute watery diarrhea is a common and serious health issue in children, especially in those who are severely malnourished. These children are at a much higher risk of complications such as dehydration, electrolyte imbalances, and even death. Oral Rehydration Solutions (ORS) are a widely used treatment to prevent and correct dehydration in such children. However, there are different types of ORS, and it is still unclear which one is more effective and safer for use in severely malnourished children.
This clinical study is being conducted at The Children's Hospital, Lahore, to compare two different types of ORS: low osmolar ORS and ReSoMal (a special rehydration solution designed for malnourished children). The aim is to determine which solution is more effective in correcting low potassium levels (a common problem in these children) and to identify which one has fewer side effects, particularly problems like low or high sodium levels that can be dangerous.
A total of 72 children between 6 months and 5 years of age, all diagnosed with severe malnutrition and mild to moderate dehydration due to acute watery diarrhea, will be included in the study. They will be randomly assigned to receive either low osmolar ORS or ReSoMal. Blood tests will be done before and after the treatment to check for changes in electrolyte levels. The frequency of diarrhea and the child's overall response to treatment will also be recorded.
The hypothesis of this study is that there is a significant difference in both effectiveness and side effects between the two ORS solutions. The results of this study will help doctors choose the safest and most effective ORS for treating diarrhea in severely malnourished children, improving care and potentially saving lives.
Detailed description
After approval from ethical review committee of the hospital, 72 (36 in each group) severe malnourished children with watery diarrhea who present in the Department of Pediatrics Medicine University of Child Health Sciences,The Children's hospital Lahore will be included. Parents of the children who fulfill the above criteria will be counseled and explained the details of the study. Written informed consent and detailed history will be taken from each patient parent related to duration and frequency diarrhea. They will be divided into the following two groups using lottery method.
Group-I: Low osmolar ORS. (mmol/L: Na+ 75, K+ 20, Cl- 65, citrate 10, glucose 75, and osmolarity 245) Group-II: ReSoMal ORS. (Na 45 mmol/L, K 40 mmol/L, Cl 76 mmol/L, citrate 7 mmol/L, Mg 6 mmol/L, Zn 300 lmol/ L, Cu 45 lmol/L, glucose 125 mmol/L, osmolarity 300 mmol/L) At arrival in the hospital the dehydration status of the children will be assessed using the dehydration severity score (appendix). The weight of each child along with the height will be noted and I/V lines saved under aseptic measure. Base line investigations including the electrolytes and renal function tests will be sent to the lab and appropriate management of the infection with suitable antibiotics will be started. Fluid deficit will be corrected with 10 mL/kg/h of the assigned ORS given over the first 2 hours, then 5 mL/kg/h over a period of 10 to 12 hours until the deficit is corrected. Ongoing stool losses will be corrected with 5mL/kg after each watery or loose stool. The patients in group-I will receive low osmolar ORS fluid while the patients in group-II will receive standard ORS fluid. 24 hours after the fluid therapy started, blood will be drawn and will be sent for the measurement of electrolytes. The efficacy and side effects will be labelled as per operational definition. The frequency of passage of stool in the 24 hours will also be noted.
All data along will the lab values will be recorded into the attached performa, and all the labs will be done from the hospital lab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Low Osmolar ORS | Experimental | Drug: Low Osmolar ORSReceived low osmolar oral rehydration solution (ORS) with an osmolarity of 245 mmol/L and sodium 75 mmol/L, administered orally according to WHO guidelines for rehydration in diarrhea. |
| Group ReSoMal | Active comparator | Drug: ReSoMalReceived ReSoMal oral rehydration solution specifically formulated for malnourished children, with lower sodium and higher potassium content, administered orally. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children aged 6 months to 5 years.
- Both male and female.
- Children presenting with acute watery diarrhea.
- Children have mild to moderate dehydration.
- Children have serum sodium (135-145 mEq/L) and serum Potassium (2.5-3.4 mEq/L).
Key exclusion criteria (4 listed)
- Critically ill children with shock, history of not passed urine for 6 h, convulsions and electrolyte abnormality requiring intravenous (IV) for severe dehydration.
- History of chronic gastrointestinal disorders, such as inflammatory bowel disease or celiac disease.
- Received antibiotics within 48 hours before enrollment.
- Children having any systemic illness requiring hospitalization or specific treatment, such as sepsis or pneumonia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Osmolar ORSComposition: Na⁺ 75 mmol/L, K⁺ 20 mmol/L, Cl- 65 mmol/L, citrate 10 mmol/L, glucose 75 mmol/L; osmolarity 245 mmol/L. Administered orally in rehydration regimen over 24 hours. | Drug | Group Low Osmolar ORS |
| ReSoMalComposition: Na⁺ 45 mmol/L, K⁺ 40 mmol/L, Cl- 76 mmol/L, citrate 7 mmol/L, glucose 125 mmol/L, Mg 6 mmol/L, Zn 300 µmol/L, Cu 45 µmol/L; osmolarity 300 mmol/L. Administered orally over 24 hours according to rehydration protocol. | Drug | Group ReSoMal |
Primary outcome
Correction of Hypokalemia After 24 Hours of Oral Rehydration
Time frame: 24 hours after initiation of oral rehydration therapy
This outcome assesses the proportion of participants whose serum potassium levels normalize after 24 hours of treatment with either low osmolar ORS or ReSoMal. Hypokalemia is defined as serum potassium <3.5 mmol/L. Correction is considered achieved if serum potassium rises to ≥3.5 mmol/L without requiring intravenous potassium supplementation.
1 secondary outcome
Incidence of Hyponatremia and Hypernatremia After 24 Hours of Oral Rehydration
Time frame: 24 hours after initiation of oral rehydration therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sadaf Sumreen principal investigator
University Of Child Health Sciences, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Osmolar ORS and ReSoMal in people with Acute Watery Diarrhea and Severe Acute Malnutrition in Childhood, run by University of Child Health Sciences and Children's Hospital, Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correction of Hypokalemia After 24 Hours of Oral Rehydration (time frame: 24 hours after initiation of oral rehydration therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.