Vitamin D Deficiency and Atopic Dermatitis

NCT01337635 | Terminated Results

• 1 other identifier: CHW 10/146, GC 1169
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Atopic dermatitis is a chronic skin disease characterized by a defective skin barrier, inflammation, and increased propensity for skin infections. Vitamin D is a fat-soluble vitamin that is primarily acquired through local production in the skin after ultraviolet light exposure but can also be obtained through natural and supplemental dietary sources. This randomized controlled trial will examine the effects of vitamin D repletion on atopic dermatitis severity in patients with diagnosed deficiency. The investigators hypothesize that pediatric patients with moderate or severe atopic dermatitis and vitamin D deficiency will have improved cutaneous disease after treatment with high dose as compared to standard dose vitamin D.

Conditions

Atopic Dermatitis; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• Atopic Dermatitis Severity at the Completion of Treatment

  SCORAD at the 6 week study visit. The SCORAD (SCORing Atopic Dermatitis) is a clinical tool used to assess the extent and severity of eczema. The SCORAD is scored 0-103, with a higher score indicating more severe atopic dermatitis (worse outcome).

  6 weeks

Secondary Outcomes (1)

• Time to Restart Topical Steroids

  6 weeks

Study Arms (2)

Standard dose vitamin D

ACTIVE COMPARATOR

Treatment with cholecalciferol 400 IU daily at home.

Drug: Vitamin D

High dose vitamin D

ACTIVE COMPARATOR

Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.

Drug: Vitamin D

Interventions

Vitamin D DRUG

Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks

High dose vitamin D; Standard dose vitamin D

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Serum 25-hydroxyvitamin D level \<20 ng/ml (\<50 nmol/L)
• Diagnosed with atopic dermatitis by a CHW pediatric dermatologist
• Age 1-18 years old
• Primary residence in Milwaukee County
• Moderate and severe atopic dermatitis (Severity Scoring of Atopic Dermatitis \[SCORAD\] score greater than 15)
• On clinic protocol treatment for their atopic dermatitis (desonide ointment twice daily for the face and groin, triamcinolone 0.1% ointment twice daily for other areas)

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Children's Hospital and Health System Foundation, Wisconsin: collaborator

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Vitamin D Deficiency

Interventions

Vitamin D

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; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Yvonne Chiu, MD
• Organization: Medical College of Wisconsin

ychiu@mcw.edu

414-955-2818

Study Officials

• Yvonne Chiu, MD

  Children's Hospital and Health System Foundation, Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: April 19, 2011
• Study Start: November 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: December 5, 2018
• Results First Posted: April 8, 2015

Record last verified: 2018-11

Locations

US (1)