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Softened Water for Eczema Prevention Pilot Trial

NCT03270566 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-02-19

No results posted yet for this study

Summary

An outcome assessor-blinded pilot randomised controlled trial of an ion-exchange water softener for the prevention of atopic eczema in neonates, with an embedded mechanistic study

Conditions

  • Atopic Eczema

Interventions

DEVICE

Domestic ion-exchange water softener

Ion-exchange water softeners exchange calcium and magnesium, amongst other divalent cations, for monovalent sodium cations using a polystyrene resin. The sodium ions come from sodium chloride (common salt). The salt needs to be topped up every 3-4 weeks and sufficient quantities of block salt will be supplied to participants. The water softener used in this study does not require electricity and has two cylinders of resin which are used alternately. A control valve alternates the flow between the two cylinders and ensures a constant supply of regenerated resin. Ion-exchange water softeners typically reduce downstream water hardness to close to zero.

Sponsors & Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

    collaborator OTHER

  • University of Nottingham

    collaborator OTHER

  • University of Sheffield

    collaborator OTHER

  • Imperial College London

    collaborator OTHER

  • University of Amsterdam

    collaborator OTHER

  • University of Dundee

    collaborator OTHER

  • King's College London

    lead OTHER

Principal Investigators

  • Carsten Flohr, PhD, FRCPCH · King's College London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-12
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • United Kingdom

Study Locations

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Entities

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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 NCT03270566 on ClinicalTrials.gov