Impact of Vitamin D Supplementation on Severity of Pediatric Atopic Dermatitis (VIDATOPIC)

Pontificia Universidad Catolica de Chile

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Dietary Supplement: Vitamin D3; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01996423

1130615 (Other Grant/Funding Number)

12-185

Details and patient eligibility

About

The purpose of this study is to determine whether oral vitamin D supplementation improves the clinical severity of atopic dermatitis in children. In addition, this study plans to evaluate the effects of vitamin D supplementation on several key aspects of the immune system of children with atopic dermatitis.

Enrollment: 101 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Atopic dermatitis diagnosed according to Hanifin and Rajka criteria
• Age 2 - 17 years
• SCORAD 10 - 103

Exclusion criteria

• Active skin infection
• History of underlying illness causing immunosuppression within the past 2 years
• Immunosuppressors taken within the past month
• Parathyroid disease
• Sarcoidosis
• Acute or chronic renal disease
• Hyper or hypocalcemia
• Thyroid disease
• Osteomalacia or Paget's disease of bone
• Malabsorption
• Use of VD supplements (> 400 IU daily) or fish oil supplements in the past month
• Treatment for known VD deficiency in the last 6 months
• Treatment with moderate or high potency topical corticosteroids, oral or topical antibiotics, oral antivirals, immune enhancers, or topical calcineurin inhibitors in the past 7 days
• Phototherapy in the past month
• Autoimmune disease or immunodeficiency
• Planned trip to sunny climate during the 6-week study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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101 participants in 2 patient groups, including a placebo group

Vitamin D3 supplementation

Experimental group

Description:

Subjects in the experimental arm will receive weekly vitamin D3 doses in oral suspension during 6 weeks. Weekly dose varies according to age group: VD3 8000 IU between ages 2-5.9 years, VD3 12000 IU between ages 6-11.9 years, VD3 16000 IU between ages 12-17.9 years.

Treatment:

Dietary Supplement: Vitamin D3

Placebo

Placebo Comparator group

Description:

Subjects in the placebo arm will receive weekly placebo oral suspension during 6 weeks.

Treatment:

Dietary Supplement: Placebo