NCT03270566

Brief 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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

August 31, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

February 12, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

February 19, 2018

Status Verified

August 1, 2017

Enrollment Period

1.3 years

First QC Date

August 31, 2017

Last Update Submit

February 15, 2018

Conditions

Atopic Eczema

Keywords

Water hardnessAtopic eczema preventionSkin barrier functionSkin microbiome

Outcome Measures

Primary Outcomes (1)

  • Proportion of eligible families screened who are willing and able to be randomised.

    This is key to the determination of the likely success of a future, large-scale definitive randomised controlled trial (RCT).

    Before birth

Secondary Outcomes (16)

  • Proportion of pregnant women approached who agree to be screened

    Before birth

  • Proportion of families eligible on screening that cannot have a water softener installed (e.g. due to landlord or local authority refusal, technical (plumbing) reasons)

    Before birth

  • Proportion of families randomised that withdraw due to infant ineligibility

    Baseline (birth)

  • Proportion of families in intervention arm who found the intervention acceptable

    End of follow up (6 months of age)

  • Proportion of participants in control arm that become exposed to softened water

    End of follow up (6 months of age)

  • +11 more secondary outcomes

Other Outcomes (8)

  • Transepidermal water loss (TEWL)

    at birth, 4 weeks, 3 & 6 months oif age

  • Cutaneous cytokine profiles

    at birth, 4 weeks, 3 & 6 months oif age

  • Natural moisturising factor (NMF) levels

    at birth, 4 weeks, 3 & 6 months oif age

  • +5 more other outcomes

Study Arms (2)

Domestic ion-exchange water softener

EXPERIMENTAL

The intervention group will have a domestic ion-exchange water softener installed prior to birth.

Device: Domestic ion-exchange water softener

Usual hard water supply

NO INTERVENTION

The control group will receive their usual domestic water supply.

Interventions

Domestic ion-exchange water softenerDEVICE

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.

Domestic ion-exchange water softener

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participant (i.e. the neonate) must have a parent or sibling with a history of doctor-diagnosed atopy (i.e. at least one of: eczema, asthma, hayfever)
  • Mother aged ≥18 years of age at enrolment
  • Baby \<36 weeks gestation at screening
  • Informed consent from the mother on behalf of the participant
  • Mother has the ability to understand English
  • Live in a hard water area (\>250 mg/L Calcium Carbonate)
  • Consent of landlord for installation on water softener (if appropriate)
  • Occupy a property appropriate for installation of a water softener

You may not qualify if:

  • Preterm birth (defined as birth prior to 37 weeks gestation)
  • Significant inflammatory skin disease at birth not including seborrheic dermatitis ("cradle cap")
  • Sibling (including twin) previously randomised to this trial. If multiple birth, the first child will be randomised into the trial.
  • The child is to be fostered/adopted
  • Any immunodeficiency disorder or severe genetic skin disorder
  • Child has any other serious health issue which, at parent or investigator discretion, would make it difficult for the family to take part in the trial.
  • Planned stays away from home for a continuous period of more than 2 weeks or a total of 1 month out of the 6 month follow up period
  • Water softening or filtration device already installed
  • Concurrent enrolment in any other skin-related intervention study
  • Other medical condition that in the opinion of the CI could interfere with the conduct of the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Thomas' Hospital

London, SE1 7EH, United Kingdom

RECRUITING

Related Publications (3)

  • Jabbar-Lopez ZK, Ezzamouri B, Briley A, Greenblatt D, Gurung N, Chalmers JR, Thomas KS, Frost T, Kezic S, Common JEA, Danby S, Cork MJ, Peacock JL, Flohr C. Randomized controlled pilot trial with ion-exchange water softeners to prevent eczema (SOFTER trial). Clin Exp Allergy. 2022 Mar;52(3):405-415. doi: 10.1111/cea.14071. Epub 2021 Dec 12.

    PMID: 34854157DERIVED

  • Laughter MR, Maymone MBC, Mashayekhi S, Arents BWM, Karimkhani C, Langan SM, Dellavalle RP, Flohr C. The global burden of atopic dermatitis: lessons from the Global Burden of Disease Study 1990-2017. Br J Dermatol. 2021 Feb;184(2):304-309. doi: 10.1111/bjd.19580. Epub 2020 Nov 29.

    PMID: 33006135DERIVED

  • Jabbar-Lopez ZK, Gurung N, Greenblatt D, Briley A, Chalmers JR, Thomas KS, Frost T, Kezic S, Common JEA, Kong HH, Segre JA, Danby S, Cork MJ, Peacock JL, Flohr C. Protocol for 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: the Softened Water for Eczema Prevention (SOFTER) trial. BMJ Open. 2019 Aug 20;9(8):e027168. doi: 10.1136/bmjopen-2018-027168.

    PMID: 31434765DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Carsten Flohr, PhD, FRCPCH

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zarif Jabbar-Lopez, MPH, MRCP

CONTACT

020 7188 7188zarif.jabbar-lopez@kcl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 1, 2017

Study Start

February 12, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

February 19, 2018

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

No plans to share IPD

Locations

GB(1)