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Study to see the benefits/harms of half dose ORS solution compared with normal/standard ORS in severely malnourished (severe starvation)child suffering from diarrheal illness.

Full Strength ORS vs Modified Half Strength ORS for Rehydration in Children with Severe Acute Malnutrition suffering from Diarrhea

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/10/016239
Enrollment
100
Registered
2018-10-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R00-R99- Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified Health Condition 2: E43- Unspecified severe protein-caloriemalnutrition

Interventions

Intervention1: Modified half Strength low osmolarity WHO ORS: Single WHO ORS packet containing 75 meq/L of sodium will be dissolved in two liters of clean water
50 g sucrose and 22.5 mL of potassium syrup (containing 30 mmol/L) of potassium will be added. This modified half strength solution provide less sodium (37.5 mmol/L), more potassium (40 mmol/L) and ad

Sponsors

University College of Medical Sciences and Guru Teg Bahadur Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged between 6 months -59 months, and classified as SAM according to WHO Criteria (weight for height = 3 episodes ina day

Exclusion criteria

Exclusion criteria: (i)Children with known secondary causes of SAM (e.g., Chronic renal disorders, Congenital heart diseases, cerebral palsy, Known HIV infection, Malabsorption, Celiac disease); (ii) Children presenting with acute events like shock, convulsions, congestive heart failure, coma.; (iii) Children in whom oral/nasogastric feeding not safe (e.g., bilious vomiting, surgical complications, severe respiratory distress requiring oxygen therapy)

Design outcomes

Primary

MeasureTime frame
To compare proportion of children with hyponatremia (Serum sodium 135 mEq/L) after 12 hours of rehydration in children with SAM suffering from diarrheaTimepoint: After 12 hours of rehydration.

Secondary

MeasureTime frame
a)Proportion of hypokalemia, hypoglycemia and hypernatremia b)Serum levels of sodium, potassium and glucose c)Percent weight gain (rehydration) d)Frequency of loose stool e)Amount of ORS solution intake after 12 hours of rehydration between two groups f)Duration of diarrhea Timepoint: All the parameters given above will be assessed initially at recruitment ( 0 hours ) and repeated at the end of intervention ( 12 hours ), after rehydration. point f) i.e. duration of diarrheal illness will be assessed at discharge.

Countries

India

Contacts

Public ContactNeha Kumari

University college of medical sciences

shahdheeraj@hotmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026