Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Vitamin D Supplementation in Childhood Atopic Dermatitis

This study has been completed.
Information provided by (Responsible Party):
Carlos A. Camargo, Jr., Massachusetts General Hospital Identifier:
First received: April 9, 2009
Last updated: December 20, 2016
Last verified: December 2016
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]
  • Investigator Global Assessment (IGA) [ Time Frame: 1 month ]

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.


Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00879424

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

Responsible Party: Carlos A. Camargo, Jr., Physician, Massachusetts General Hospital Identifier: NCT00879424     History of Changes
Other Study ID Numbers: CeDAR-01
Study First Received: April 9, 2009
Last Updated: December 20, 2016

Keywords provided by Massachusetts General Hospital:
vitamin D
atopic dermatitis

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on April 26, 2017