|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
9 January 2017 |
|
Main ID: |
NCT00879424 |
|
Date of registration:
|
09/04/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Vitamin D Supplementation in Childhood Atopic Dermatitis
|
|
Scientific title:
|
Randomized Trial of Vitamin D Supplementation in Winter-related, Childhood Atopic Dermatitis |
|
Date of first enrolment:
|
February 2009 |
|
Target sample size:
|
107 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00879424 |
|
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
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Mongolia
| | | | | | | |
|
Contacts
|
|
Name:
|
Carlos A. Camargo, MD, DrPH |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Massachusetts General Hospital |
| | |
|
Key inclusion & exclusion 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
Age minimum:
2 Years
Age maximum:
17 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Atopic Dermatitis
|
|
Intervention(s)
|
|
Dietary Supplement: Placebo
|
|
Dietary Supplement: cholecalciferol (vitamin D)
|
|
Primary Outcome(s)
|
|
EASI score
[Time Frame: 1 month]
|
|
Investigator Global Assessment (IGA)
[Time Frame: 1 month]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|