RecruitingPhase 2Phase 3ACTRN12612000570886

Vitamin D in the management of Childhood Atopic Dermatitis (eczema)

In children aged 2-16 with moderate to severe atopic dermatitis (eczema), is daily vitamin D3 (1000 IU/day) more effective than placebo in improving the severity of the eczema and quality of life.


Sponsor

Prof Dianne Campbell

Enrollment

150 participants

Start Date

Mar 11, 2013

Study Type

Interventional

Conditions

Summary

The project aims to show that oral vitamin D supplementation will improve the severity of childhood atopic dermatitis (eczema). We will compare the severity of disease in children with moderate-severe atopic dermatitis after 3 months of daily Vitamin D therapy or placebo, using randomised double blind placebo controlled methodology. We propose that the severity of moderate and moderate-severe atopic dermatitis will be significantly decreased by oral Vitamin D therapy. We aim to show that in these children, following 3 months of daily vitamin D3 at 1000IU, there will be a significant decrease in their disease severity and decreased use of topical corticosteroids. We aim to demonstrate a significant improvement in the quality of life for these children, as measured by a validated quality of life questionnaire.


Eligibility

Sex: Both males and femalesMin Age: 2 YearssMax Age: 16 Yearss

Inclusion Criteria3

  • Atopic dermatitis consistent with diagnostic criteria of Hanifin and Rajka.
  • Ages- 2 years- 16 years
  • Moderate-severe eczema at study entry defined as an objective SCORAD of > 15 (0-83)

Exclusion Criteria5

  • Ages <2 years or >16 years
  • Past or current history of oral immunosuppression therapy (Cyclosporin, Azathioprine, Methotrexate)
  • Oral corticosteroids < 6 months prior to study
  • IVIg therapy< 2 years prior to study
  • Hypercalcaemia, Hypertension, Anticonvulsant therapy

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Interventions

Eligible children recruited and enrolled will be randomised to receive either liquid drops of Vitamin D 3 (Cholecalciferol)(1000 IU/day) or placebo for a period of 3 months. All children enrolled will

Eligible children recruited and enrolled will be randomised to receive either liquid drops of Vitamin D 3 (Cholecalciferol)(1000 IU/day) or placebo for a period of 3 months. All children enrolled will be allowed to continue their normal skin care regime, with use of moisturisers and topical steroids throughout the study period.


Locations(1)

The Children's Hospital at Westmead - Westmead

NSW, Australia

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