Impact of Vitamin D Supplementation on Severity of Pediatric Atopic Dermatitis

NCT ID: NCT01996423

Last Updated: 2015-03-03

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

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-12-31

Brief Summary

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The purpose of this study is to determine whether oral vitamin D supplementation improves the clinical severity of atopic dermatitis in children. In addition, this study plans to evaluate the effects of vitamin D supplementation on several key aspects of the immune system of children with atopic dermatitis.

Detailed Description

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Conditions

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Atopic Dermatitis

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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Vitamin D3 supplementation

Subjects in the experimental arm will receive weekly vitamin D3 doses in oral suspension during 6 weeks. Weekly dose varies according to age group: VD3 8000 IU between ages 2-5.9 years, VD3 12000 IU between ages 6-11.9 years, VD3 16000 IU between ages 12-17.9 years.

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Placebo

Subjects in the placebo arm will receive weekly placebo oral suspension during 6 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Cholecalciferol

Eligibility Criteria

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Inclusion Criteria

* Atopic dermatitis diagnosed according to Hanifin and Rajka criteria
* Age 2 - 17 years
* SCORAD 10 - 103

Exclusion Criteria

* Active skin infection
* History of underlying illness causing immunosuppression within the past 2 years
* Immunosuppressors taken within the past month
* Parathyroid disease
* Sarcoidosis
* Acute or chronic renal disease
* Hyper or hypocalcemia
* Thyroid disease
* Osteomalacia or Paget's disease of bone
* Malabsorption
* Use of VD supplements (\> 400 IU daily) or fish oil supplements in the past month
* Treatment for known VD deficiency in the last 6 months
* Treatment with moderate or high potency topical corticosteroids, oral or topical antibiotics, oral antivirals, immune enhancers, or topical calcineurin inhibitors in the past 7 days
* Phototherapy in the past month
* Autoimmune disease or immunodeficiency
* Planned trip to sunny climate during the 6-week study.
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arturo Borzutzky, M.D.

Role: PRINCIPAL_INVESTIGATOR

School of Medicine, Pontificia Universidad Católica de Chile

Carlos A Camargo Jr., M.D., DrPH

Role: STUDY_DIRECTOR

Massachusetts General Hospital, Harvard University, Boston, USA

Cristian Vera, M.D.

Role: STUDY_DIRECTOR

School of Medicine, Pontificia Universidad Católica de Chile

Lorena Cifuentes, M.D.

Role: STUDY_DIRECTOR

School of Medicine, Pontificia Universidad Católica de Chile

Sergio Silva, M.D.

Role: STUDY_DIRECTOR

School of Medicine, Pontificia Universidad Católica de Chile

Locations

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School of Medicine, Pontificia Universidad Católica de Chile

Santiago, , Chile

Site Status

Countries

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Chile

References

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Borzutzky A, Iturriaga C, Perez-Mateluna G, Cristi F, Cifuentes L, Silva-Valenzuela S, Vera-Kellet C, Cabalin C, Hoyos-Bachiloglu R, Navarrete-Dechent C, Cossio ML, Le Roy C, Camargo CA Jr. Effect of weekly vitamin D supplementation on the severity of atopic dermatitis and type 2 immunity biomarkers in children: A randomized controlled trial. J Eur Acad Dermatol Venereol. 2024 Sep;38(9):1760-1768. doi: 10.1111/jdv.19959. Epub 2024 Mar 14.

Reference Type DERIVED
PMID: 38483248 (View on PubMed)

Other Identifiers

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1130615

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

12-185

Identifier Type: -

Identifier Source: org_study_id

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