NCT04677296

Brief Summary

Randomized double blinded clinical trial comparing amino acid based oral rehydration solution/medical food and glucose-based oral rehydration solution is infectious diarrhea in pediatric population

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
312

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

June 16, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2022

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

November 17, 2020

Last Update Submit

March 21, 2023

Conditions

Diarrhea, Infantile

Outcome Measures

Primary Outcomes (1)

  • Duration of diarrhea in hospital (hours)

    number of hours of diarrhea after randomization

    5 days

Secondary Outcomes (11)

  • Stool output

    1 day

  • Total stool output

    5 days

  • ORS intake in the 1st 24 hours of hospitalization

    1 day

  • Total ORS intake

    5 days

  • Unscheduled IV (frequency/ORS group)

    5 days

  • +6 more secondary outcomes

Study Arms (2)

VS002A

EXPERIMENTAL

Amino acid based ORS/medical food (VS002A). Initial treatment dosing with VS002A will be estimated using body weight in accordance with 5-10 ml/kg after each loose stool as per icddr,b guidelines, to maintain ongoing loss.

Other: VS002A

Standard WHO-ORS

ACTIVE COMPARATOR

Standard WHO-ORS. Initial treatment dosing with WHO-ORS will be estimated using body weight in accordance with 5-10 ml/kg after each loose stool as per icddr,b guidelines, to maintain ongoing loss.

Other: WHO-ORS

Interventions

VS002AOTHER

Amino acid based ORS/Medical food

VS002A
WHO-ORSOTHER

WHO Oral rehydration solution, which is glucose based

Standard WHO-ORS

Eligibility Criteria

Age6 Months - 36 Months
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMeasuring stool output on a diaper on female children will create a bias since it will be mixed with urine.
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age: 6 months - 36 months,
  • Duration of diarrhea ≤48 hours,
  • Some dehydration (judged clinically according to the "Dhaka method"),
  • Written informed consent by either parent/guardian.

You may not qualify if:

  • Severe malnutrition (Weight-for-length WLZ/WHZ/WAZ \<-3 or presence of nutritional edema)
  • Patients with diarrhea due to cholera.
  • Systemic illness (e.g. Pneumonia, tuberculosis, enteric fever, meningitis etc.)
  • Bloody diarrhea
  • Any congenital anomaly or disorder (e.g. diagnosed inborn error of metabolism, congenital cardiac disease, seizure disorders, hypothyroidism, Down's syndrome etc.)
  • Requirement of additional intravenous fluids after being provided with an IV for 4 hours on admission if severely dehydrated
  • Has documentation of taking antibiotic and/or antidiarrheal within the last 48 hours prior to hospitalization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICDDR,B

Dhaka, Bangladesh

Location

Related Publications (1)

  • Das R, Sobi RA, Sultana AA, Nahar B, Bardhan PK, Luke L, Fontaine O, Ahmed T. A double-blind clinical trial to compare the efficacy and safety of a multiple amino acid-based ORS with the standard WHO-ORS in the management of non-cholera acute watery diarrhea in infants and young children: "VS002A" trial protocol. Trials. 2022 Aug 25;23(1):706. doi: 10.1186/s13063-022-06601-5.

    PMID: 36008819DERIVED

MeSH Terms

Conditions

Diarrhea, Infantile

Interventions

World Health Organization oral rehydration solution

Condition Hierarchy (Ancestors)

DiarrheaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tahmeed Ahmed, MD

    International Centre for Diarrhoeal Disease Research, Bangladesh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized double blinded
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2020

First Posted

December 21, 2020

Study Start

June 16, 2021

Primary Completion

September 5, 2022

Study Completion

September 5, 2022

Last Updated

March 22, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

BA(1)