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

Plain Language Summary

Simplified for easier understanding

This study is testing whether daily vitamin D supplements can reduce the severity of moderate-to-severe eczema (atopic dermatitis) in children. Eczema is a common skin condition causing itchy, inflamed skin. Some research suggests low vitamin D levels may make eczema worse, and this study will compare 1000 IU of vitamin D3 daily with a placebo (inactive pill) over 3 months to see if there is a difference in eczema severity and quality of life. You may be eligible if: - Your child is between 2 and 16 years old - Your child has been diagnosed with atopic dermatitis (eczema) that meets standard diagnostic criteria - Your child has moderate-to-severe eczema at the time of entering the study (SCORAD score above 15) You may NOT be eligible if: - Your child is under 2 or over 16 years old - Your child has previously taken or is currently taking oral immunosuppressive medications (like cyclosporin, azathioprine, or methotrexate) - Your child has taken oral corticosteroids within the past 6 months - Your child has received intravenous immunoglobulin (IVIg) therapy within the past 2 years - Your child has hypercalcaemia (high calcium), high blood pressure, or takes anticonvulsant medications Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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ACTRN12612000570886


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