Vitamin D Supplementation in Childhood Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

Randomized Trial of Vitamin D Supplementation in Winter-related, Childhood Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879424
• Other study ID #: CeDAR-01
• Status: Completed
• Phase: N/A
• First received: April 9, 2009
• Last updated: December 20, 2016
• Start date: February 2009
• Est. completion date: May 2009

Study information

• Verified date: December 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.
• Placebo
1000 IU once daily x 1 month Experimental group will receive Ddrops (Toronto, Canada). Placebo group will receive placebo drops.

Locations

Country	Name	City	State
Mongolia	National Dermatology Center	Ulaan Baatar

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

Mongolia, 

References & Publications (2)

Camargo CA Jr, Ganmaa D, Sidbury R, Erdenedelger Kh, Radnaakhand N, Khandsuren B. Randomized trial of vitamin D supplementation for winter-related atopic dermatitis in children. J Allergy Clin Immunol. 2014 Oct;134(4):831-835.e1. doi: 10.1016/j.jaci.2014. — View Citation

Sidbury R, Sullivan AF, Thadhani RI, Camargo CA Jr. Randomized controlled trial of vitamin D supplementation for winter-related atopic dermatitis in Boston: a pilot study. Br J Dermatol. 2008 Jul;159(1):245-7. doi: 10.1111/j.1365-2133.2008.08601.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EASI score		1 month	No
Primary	Investigator Global Assessment (IGA)		1 month	No