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Clinical Trial Details for Can Vitamin D Treatment Help Treat Moderate to Severe Atopic Dermatitis in Young Children? The D-Vex Pilot Study


Murdoch Childrens Research Institute
NCT ID: NCT03257215
Last Updated: June 7, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 4
  • Gender: All
  • Age: 1 Year - 12 Years
  • Condition: Atopic Dermatitis
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: Murdoch Childrens Research Institute
  • Location: Not Provided

Official Title

A Phase IV, Double-blind, Randomised, Placebo-controlled Trial to Assess the Efficacy and Safety of Stoss Versus Daily Dose Oral Vitamin D Compared to Placebo for the Treatment of Atopic Dermatitis in Pre-school Aged Children- a Pilot Study

Purpose

Vitamin D is known to have a regulatory influence on both the immune system and skin barrier function. Studies in paediatric populations have found an inverse association of vitamin D levels and with both prevalence and severity of atopic dermatitis (AD). Trials of vitamin D as a treatment for AD are limited in number and size. There has never been a placebo-controlled randomised controlled trial of stoss high dose versus daily standard dose for the treatment of AD. Further, no trials have explored the presence of vitamin D pathway genes and response to treatment of AD. This pilot study will be used as a reference to determine outcomes and feasibility for undertaking a larger and more in depth definitive study.

Eligibility

Ages Eligible for Study

1 Year to 12 Years

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

– moderate to severe atopic dermatitis with a SCORAD ≥ 20 at baseline.

– aged between 1 ≤ 12 years of age at the time of randomisation.

– regularly ingest the recommended dietary intake (RDI) of calcium and plan to do so for
the next 3 months

– have a legally acceptable representative capable of understanding the informed consent
document and providing consent on the participant’s behalf.

Exclusion Criteria:

– use of vitamin D supplementation, including a stoss dose of vitamin D in the previous
year, or daily supplementation in the past month

– drink vitamin D fortified formula (all formulas) as the main milk intake

– received oral steroids within the past 6 months

– received oral immunosuppression in the past (cyclosporine, azathioprine, methotrexate)

– received UV therapy in the past 12 months

– have been fully formula fed within the past 6 months

– ave renal or liver or gastrointestinal (e.g.: coeliac, inflammatory bowel disease)
disease

– receiving thiazide-type diuretics or anticonvulsant therapy

– have ever been diagnosed with Hypercalcaemia, Hypertension or Rickets

– unable to provide consent without the aid of an interpreter

– in the opinion of the Investigator, are unable to follow the protocol

Additional Information, Locations & Contacts

Sponsors & Collaborators

Murdoch Childrens Research Institute

Investigators

Principal Investigator: Kirsten P Perrett, MBBS

Murdoch Children's Research Institute

Please refer to this study by its ClinicalTrials.gov identifier: NCT03257215

Location

Contacts

Royal Children's Hospital Melbourne

Melbourne, Victoria 3052

Australia

Kirsten P Perrett, MBBS