Impact of Vitamin D Supplementation on Severity of Pediatric Atopic Dermatitis

NCT01996423 | Completed

• 2 other identifiers: 12-1851130615
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; vitamin D

Outcome Measures

Primary Outcomes (1)

• Change in SCORAD index

  Change in Scoring Atopic Dermatitis (SCORAD) index after 6 weeks of vitamin D3 (VD3) supplementation or placebo in children with atopic dermatitis.

  baseline and 6 weeks

Secondary Outcomes (5)

• Changes in Th2 immunity

  baseline and 6 weeks

• Change in dendritic cell-mediated tolerance and regulatory T cells

  baseline and 6 weeks

• Effect of VD3 supplementation on immunity to Staphylococcus aureus

  baseline and 6 weeks

• Vitamin D receptor single nucleotide polymorphisms

  baseline and 6 weeks

• Change in epidermal protein expression

  6 weeks

Other Outcomes (1)

• Number of participants with adverse events

  6 weeks

Study Arms (2)

Vitamin D3 supplementation

EXPERIMENTAL

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.

Dietary Supplement: Vitamin D3

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Also known as: Cholecalciferol

Vitamin D3 supplementation

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

School of Medicine, Pontificia Universidad Católica de Chile

Santiago, Chile

Location

Related Publications (1)

• Borzutzky A, Iturriaga C, Perez-Mateluna G, Cristi F, Cifuentes L, Silva-Valenzuela S, Vera-Kellet C, Cabalin C, Hoyos-Bachiloglu R, Navarrete-Dechent C, Cossio ML, Le Roy C, Camargo CA Jr. Effect of weekly vitamin D supplementation on the severity of atopic dermatitis and type 2 immunity biomarkers in children: A randomized controlled trial. J Eur Acad Dermatol Venereol. 2024 Sep;38(9):1760-1768. doi: 10.1111/jdv.19959. Epub 2024 Mar 14.

  PMID: 38483248 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Arturo Borzutzky, M.D.

  School of Medicine, Pontificia Universidad Católica de Chile

  PRINCIPAL INVESTIGATOR

• Carlos A Camargo Jr., M.D., DrPH

  Massachusetts General Hospital, Harvard University, Boston, USA

  STUDY DIRECTOR

• Cristian Vera, M.D.

  School of Medicine, Pontificia Universidad Católica de Chile

  STUDY DIRECTOR

• Lorena Cifuentes, M.D.

  School of Medicine, Pontificia Universidad Católica de Chile

  STUDY DIRECTOR

• Sergio Silva, M.D.

  School of Medicine, Pontificia Universidad Católica de Chile

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 27, 2013
• Study Start: April 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 3, 2015

Record last verified: 2015-02

Locations

CL (1)