Vitamin D Supplementation in Childhood Atopic Dermatitis

NCT ID: NCT00879424

Last Updated: 2016-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atopic Dermatitis

Keywords

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vitamin D atopic dermatitis eczema winter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

cholecalciferol (vitamin D)

Intervention Type DIETARY_SUPPLEMENT

1000 IU once daily x 1 month

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

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

1000 IU once daily x 1 month

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

Interventions

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cholecalciferol (vitamin D)

1000 IU once daily x 1 month

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

1000 IU once daily x 1 month

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Carlos A. Camargo, Jr.

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos A. Camargo, MD, DrPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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National Dermatology Center

Ulaanbaatar, , Mongolia

Site Status

Countries

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Mongolia

References

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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. Epub 2008 Jul 1. No abstract available.

Reference Type BACKGROUND
PMID: 18489598 (View on PubMed)

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.2014.08.002.

Reference Type RESULT
PMID: 25282565 (View on PubMed)

Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.

Reference Type DERIVED
PMID: 33305842 (View on PubMed)

Other Identifiers

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CeDAR-01

Identifier Type: -

Identifier Source: org_study_id