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.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000570886

Acronym

ADDVIT

Enrollment

Registered

2012-05-28

Start date

2013-03-11

Completion date

2018-12-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 be allowed to continue their normal skin care regime, with use of moisturisers and topical steroids throughout the study period.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

2 Years to 16 Years

Healthy volunteers

Inclusion criteria

Inclusion criteria- 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 criteria

Exclusion Criteria 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

Outcome results