MedTrace Logo

Safety, Acceptability, and Feasibility of Enterade®

NCT03782272 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-02-04

Study results available
· View outcomes & findings →

Summary

This is a randomized, double-blinded, placebo-controlled pilot study to determine the safety, acceptability, and feasible pediatric dosage/tolerability of enterade® solution, an amino acid-based oral rehydration solution (AA-ORS), for potential use in the management of environmental enteric dysfunction (EED) among children aged 12-24 months in Kakamega County, Kenya.

Primary objectives:

1. To determine the safety of a 2-week course of AA-ORS among children with length-for-age Z-scores (LAZ) between -1 and -3.
2. To determine the feasibility and best tolerated dose of AA-ORS among children with LAZ between -3 and -1.

Secondary objectives:
3. To determine the perceptions among caregivers on the acceptability of AA-ORS as a potential intervention for EED. (Qualitative)

Exploratory objectives:
4. To determine the impact of AA-ORS on markers of metabolism, gut dysfunction, systemic inflammation, and micronutrient status among children with LAZ between -3 and - 1.

Qualitative results will not be reported on ClinicalTrials.gov.

Conditions

  • Stunting
  • Environmental Enteric Dysfunction

Interventions

DIETARY_SUPPLEMENT

Enterade

enterade® (an amino acid-based oral rehydration solution \[AA-ORS\]) is a medical food product that consists of oral rehydration salts, natural flavor, steviol (sweetener), purified water, and a blend of amino acids that drive the uptake of water and electrolytes.

DIETARY_SUPPLEMENT

Placebo

a placebo solution containing natural flavor, steviol (sweetener), and purified water.

Sponsors & Collaborators

  • Maseno University

    collaborator OTHER

  • Kakamega County General Teaching & Referral Hospital

    collaborator OTHER

  • PATH

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-26
Primary Completion
2019-03-20
Completion
2020-06-30

Countries

  • Kenya

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03782272 on ClinicalTrials.gov