Efficacy of a gel hypotonic oral rehydration solution in children with acute diarrhea

A randomised controlled trial evaluating the efficacy of new hypotonic oral rehydration solution containing Zinc (Zn2+) in gel to reduce diarrhea severity and duration in children with acute diarrhea

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000028606

Enrollment

Registered

2014-01-09

Start date

2012-01-09

Completion date

2012-06-14

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

All children aged 5 to 36 months observed in pediatrician offices for diarrhea lasting less than 24 hours with mild-moderate dehydration were considered eligible for the study. the patients were randomly allocated to: Group 1 receiving standard hypotonic oral rehydration solution; or to Group 2 receiving a hypotonic super-oral rehydration solution containing zinc2+ in gel formulation. The parents of enrolled children were instructed to record on a specific form: (a) amount of oral rehydration solution consumed by the child in the first 4 and 24 hours; (b) number and consistency of fecal outputs at 24, 48 and 72 hours; (c) time of the last abnormal (loose or liquid) stools preceding a normal evacuation; (d) occurrence of vomiting or adverse events.

Interventions

New hypotonic super-oral rehydration solution containing Zinc2+(Zn2+) in gel formulation, it is used to replace fluid and electrolyte losses caused by diarrhea in children with mild to moderate dehydration. The solution contains: Sodium 45mmol/L Potassium 20mmol/L Chlorine 40mmol/L Glucose 80mmol/L Citrate 10mmol/L Zinc 1mmol/L The recommended dosage is over 10ml/kg/day, every 4 hours until cessation of symptoms. The follow up was conducted for 72 hours .

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

5 Months to 36 Months

Healthy volunteers

Inclusion criteria

diarrhea lasting less than 24 hours with mild-moderate dehydration

Exclusion criteria

malnutrition; severe dehydration; concomitant severe acute or chronic systemic illness; immunodeficiency; cystic fibrosis; food allergy; chronic gastrointestinal diseases; endocrine diseases; use of pre/pro/symbiotics, antibiotics or any anti-diarrheal medication in the previous 3 weeks.

Outcome results