Vitamin D Deficiency and Atopic Dermatitis

This study has been terminated.
(Not meeting enrollment goals.)
Sponsor:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
Yvonne Chiu, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01337635
First received: November 3, 2010
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Atopic Dermatitis
Vitamin D Deficiency
Drug: Vitamin D

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Treatment Of Vitamin D Deficiency And Effect On Atopic Dermatitis Severity

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Atopic dermatitis severity at the completion of treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The SCORAD (Severity Scoring of Atopic Dermatitis) is a clinical measurement tool assessing the severity of atopic dermatitis. The range of SCORAD measurements is 0-103. The primary study endpoint will be the SCORAD score at the end of the 6 week treatment period.


Secondary Outcome Measures:
  • Time to restart topical steroids [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The time to restart topical steroids and the SCORAD score at time of restart will be secondary study endpoints.


Enrollment: 7
Study Start Date: November 2010
Study Completion Date: April 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard dose vitamin D
Treatment with cholecalciferol 400 IU daily at home.
Drug: Vitamin D
Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks
Active Comparator: High dose vitamin D
Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.
Drug: Vitamin D
Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337635

Locations
United States, Wisconsin
Children's Hospital of Wisconsin
MIlwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Investigators
Principal Investigator: Yvonne Chiu, MD Children's Hospital and Health System Foundation, Wisconsin
  More Information

No publications provided

Responsible Party: Yvonne Chiu, Assistant Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01337635     History of Changes
Other Study ID Numbers: CHW 10/146, GC 1169
Study First Received: November 3, 2010
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Vitamin D Deficiency
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 20, 2014