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Softened Water for Eczema Prevention Pilot Trial (SOFTER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03270566
Recruitment Status : Unknown
Verified August 2017 by King's College London.
Recruitment status was:  Recruiting
First Posted : September 1, 2017
Last Update Posted : February 19, 2018
Sponsor:
Collaborators:
Guy's and St Thomas' NHS Foundation Trust
University of Nottingham
University of Sheffield
Imperial College London
University of Amsterdam
University of Dundee
Information provided by (Responsible Party):
King's College London

Study Description
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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

Condition or disease Intervention/treatment Phase
Atopic Eczema Device: Domestic ion-exchange water softener Not Applicable

Detailed Description:

A 6-month parallel group assessor-blinded pilot randomised controlled trial of an ion-exchange water softener for the prevention of eczema in neonates, with an embedded mechanistic study.

The overall rationale is that by installing a domestic water softener around the time of birth, the infant will be exposed to softened water rather than hard water for bathing and that this will be less irritating to the skin than hard water and so associated with a lower risk of eczema development. The primary objective is to determine the feasibility of conducting a subsequent definitive RCT that will investigate whether installation of a domestic water softener around the time of birth can prevent eczema in high-risk babies. The secondary objective is to explore the likely mechanisms by which water softeners might prevent eczema.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Domestic ion-exchange water softener
The intervention group will have a domestic ion-exchange water softener installed prior to birth.
 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.
No Intervention: Usual hard water supply
The control group will receive their usual domestic water supply.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of eligible families screened who are willing and able to be randomised. [ Time Frame: Before birth ]
    This is key to the determination of the likely success of a future, large-scale definitive randomised controlled trial (RCT).


Secondary Outcome Measures :
  1. Proportion of pregnant women approached who agree to be screened [ Time Frame: Before birth ]
  2. 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) [ Time Frame: Before birth ]
  3. Proportion of families randomised that withdraw due to infant ineligibility [ Time Frame: Baseline (birth) ]
  4. Proportion of families in intervention arm who found the intervention acceptable [ Time Frame: End of follow up (6 months of age) ]
  5. Proportion of participants in control arm that become exposed to softened water [ Time Frame: End of follow up (6 months of age) ]
    (e.g. by moving to a new home in a soft water area, or moving to a home with an active water softener installed, before the end of follow up)

  6. Proportion of participants that have the water softening unit removed or disabled prior to end of follow up [ Time Frame: End of follow up (6 months of age) ]
  7. Proportion of participants with visible eczema status (yes/no) recorded [ Time Frame: Baseline, 4 weeks, 3 and 6 months ]
    According to UK diagnostic criteria-based photographic protocol

  8. Proportion of water samples with hardness >20 mg/L calcium carbonate [ Time Frame: Between installation and end of follow up ]
    Would suggest failure of the water softening device

  9. Proportion of participants that withdraw from the trial prior to end of follow up [ Time Frame: From randomisation until end of follow up ]
  10. Median number of nights spent away from the participant's main home during follow up [ Time Frame: From birth until end of follow up (6 months of age) ]
  11. Proportion of clinical outcome assessments that have remained blinded [ Time Frame: at 4 weeks, 3 & 6 months ]
  12. Proportion with patient-reported, doctor-diagnosed eczema [ Time Frame: by 6 months of age ]
  13. Proportion with visible eczema according to the UK diagnostic criteria-based photographic protocol [ Time Frame: 4 weeks, 3 & 6 months ]
  14. Severity of eczema (if present) using Eczema Area and Severity Index (EASI) [ Time Frame: 4 weeks, 3 & 6 months ]
  15. Patient-reported eczema symptoms (Patient-Orientated Eczema Measure - POEM) [ Time Frame: Monthly from 4 weeks to 6 months of age ]
  16. Time to onset of patient-reported doctor-diagnosed eczema [ Time Frame: from birth to end of follow up (6 months of age) ]

Other Outcome Measures:
  1. Transepidermal water loss (TEWL) [ Time Frame: at birth, 4 weeks, 3 & 6 months oif age ]
  2. Cutaneous cytokine profiles [ Time Frame: at birth, 4 weeks, 3 & 6 months oif age ]
    e.g. interleukin-1 levels

  3. Natural moisturising factor (NMF) levels [ Time Frame: at birth, 4 weeks, 3 & 6 months oif age ]
  4. Shannon Diversity Index and other skin and respiratory microbiota parameters [ Time Frame: at birth, 4 weeks, 3 & 6 months oif age ]
  5. Proportion with filaggrin null mutations [ Time Frame: at birth, 4 weeks, 3 & 6 months oif age ]
  6. Effect of filaggrin (FLG) gene mutation status on TEWL, cytokine levels, NMF levels and skin microbiota diversity [ Time Frame: at birth, 4 weeks, 3 & 6 months oif age ]
  7. Median domestic water hardness level (calcium carbonate concentration) [ Time Frame: at birth, 4 weeks, 3 & 6 months oif age ]
  8. Skin hydration [ Time Frame: at birth, 4 weeks, 3 & 6 months oif age ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270566


Contacts
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Contact: Zarif Jabbar-Lopez, MPH, MRCP 020 7188 7188 ext 57716 zarif.jabbar-lopez@kcl.ac.uk

Locations
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United Kingdom
St Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: Zarif Jabbar-Lopez, MPH MRCP    02071887188 ext 57716    zarif.jabbar-lopez@kcl.ac.uk   
Sponsors and Collaborators
King's College London
Guy's and St Thomas' NHS Foundation Trust
University of Nottingham
University of Sheffield
Imperial College London
University of Amsterdam
University of Dundee
Investigators
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Principal Investigator: Carsten Flohr, PhD, FRCPCH King's College London
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03270566    
Other Study ID Numbers: IRAS 233005
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by King's College London:
Water hardness
Atopic eczema prevention
Skin barrier function
Skin microbiome
Additional relevant MeSH terms:
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Dermatitis, Atopic
Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
 Skin Diseases, Genetic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases