Status:
TERMINATED
Can Vitamin D Treatment Help Treat Moderate to Severe Atopic Dermatitis in Young Children? the D-Vex Pilot Study
Lead Sponsor:
Murdoch Childrens Research Institute
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
1-12 years
Phase:
PHASE4
Brief Summary
Vitamin D is known to have a regulatory influence on both the immune system and skin barrier function. Studies in paediatric populations have found an inverse association of vitamin D levels and with ...
Eligibility Criteria
Inclusion
- moderate to severe atopic dermatitis with a SCORAD ≥ 20 at baseline.
- aged between 1 ≤ 12 years of age at the time of randomisation.
- regularly ingest the recommended dietary intake (RDI) of calcium and plan to do so for the next 3 months
- have a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
Exclusion
- use of vitamin D supplementation, including a stoss dose of vitamin D in the previous year, or daily supplementation in the past month
- drink vitamin D fortified formula (all formulas) as the main milk intake
- received oral steroids within the past 6 months
- received oral immunosuppression in the past (cyclosporine, azathioprine, methotrexate)
- received UV therapy in the past 12 months
- have been fully formula fed within the past 6 months
- ave renal or liver or gastrointestinal (e.g.: coeliac, inflammatory bowel disease) disease
- receiving thiazide-type diuretics or anticonvulsant therapy
- have ever been diagnosed with Hypercalcaemia, Hypertension or Rickets
- unable to provide consent without the aid of an interpreter
- in the opinion of the Investigator, are unable to follow the protocol
Key Trial Info
Start Date :
October 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2025
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03257215
Start Date
October 16 2017
End Date
January 30 2025
Last Update
March 14 2025
Active Locations (1)
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1
Royal Children's Hospital Melbourne
Melbourne, Victoria, Australia, 3052