Vitamin D Supplementation in Childhood Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carlos A. Camargo, Jr., Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00879424
First received: April 9, 2009
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

The goal of this clinical trial is to investigate the therapeutic role of vitamin D supplementation in a subset of patients with atopic dermatitis (AD): children with disease onset or worsening in the winter. The investigators hypothesis is that (1) vitamin D supplementation in patients with either wintertime onset or exacerbation of AD will improve Eczema Area and Severity Index (EASI) scores, and (2) vitamin D supplementation will improve the Investigator's Global Assessment.


Condition Intervention
Atopic Dermatitis
Dietary Supplement: cholecalciferol (vitamin D)
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Vitamin D Supplementation in Winter-related, Childhood Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • EASI score [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Investigator Global Assessment (IGA) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: February 2009
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Dietary Supplement: cholecalciferol (vitamin D)

1000 IU once daily x 1 month

Experimental group will receive Ddrops (Toronto, Canada). Placebo group will receive placebo drops.

Other Names:
  • Experimental group will receive Ddrops (Toronto, Canada).
  • Placebo group will receive placebo drops.
Placebo Comparator: 2 Dietary Supplement: Placebo

1000 IU once daily x 1 month

Experimental group will receive Ddrops (Toronto, Canada). Placebo group will receive placebo drops.


  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 2-17 years
  • AD rated 10-72 by EASI scale
  • Wintertime onset or exacerbation of AD

Exclusion Criteria:

  • Active skin infection
  • History of summertime onset or exacerbation of AD
  • History of underlying illness causing immunosuppression within the past 2 years (eg. hematologic malignancies)
  • Medications causing iatrogenic immunosuppression (eg. cyclosporine; azathioprine, oral steroids) taken within the past month
  • Parathyroid disease
  • Acute or chronic renal disease
  • Hypercalcemia or hypocalcemia
  • Thyroid disease
  • History of osteomalacia or Paget's disease of bone
  • History of malabsorption (eg cystic fibrosis)
  • Planned trip to sunny climate during the one-month study
  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: NCT00879424

Locations
Mongolia
National Dermatology Center
Ulaan Baatar, Mongolia
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Carlos A. Camargo, MD, DrPH Massachusetts General Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Carlos A. Camargo, Jr., Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00879424     History of Changes
Other Study ID Numbers: CeDAR-01
Study First Received: April 9, 2009
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
vitamin D
atopic dermatitis
eczema
winter

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

ClinicalTrials.gov processed this record on September 30, 2014