Trial Outcomes & Findings for Vitamin D Deficiency and Atopic Dermatitis (NCT NCT01337635)

NCT ID: NCT01337635

Last Updated: 2018-12-05

Results Overview

SCORAD at the 6 week study visit. The SCORAD (SCORing Atopic Dermatitis) is a clinical tool used to assess the extent and severity of eczema. The SCORAD is scored 0-103, with a higher score indicating more severe atopic dermatitis (worse outcome).

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2018-12-05

Participant Flow

Participant milestones

Measure	Standard Dose Vitamin D Treatment with cholecalciferol 400 IU daily at home. Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks	High Dose Vitamin D Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic. Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks
Overall Study STARTED	3	4
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Standard Dose Vitamin D Treatment with cholecalciferol 400 IU daily at home. Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks	High Dose Vitamin D Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic. Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Vitamin D Deficiency and Atopic Dermatitis

Baseline characteristics by cohort

Measure	Standard Dose Vitamin D n=3 Participants Treatment with cholecalciferol 400 IU oral daily at home for 6 weeks	High Dose Vitamin D n=4 Participants Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	9 years n=5 Participants	5 years n=7 Participants	6.7 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

SCORAD at the 6 week study visit. The SCORAD (SCORing Atopic Dermatitis) is a clinical tool used to assess the extent and severity of eczema. The SCORAD is scored 0-103, with a higher score indicating more severe atopic dermatitis (worse outcome).

Outcome measures

Measure	Standard Dose Vitamin D n=3 Participants Treatment with cholecalciferol 400 IU daily at home. Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks	High Dose Vitamin D n=3 Participants Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic. Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks
Atopic Dermatitis Severity at the Completion of Treatment	33.1 score on a scale Interval 25.6 to 43.4	15.5 score on a scale Interval 3.5 to 30.2

SECONDARY outcome

Timeframe: 6 weeks

The time to restart topical steroids.

Outcome measures

Measure	Standard Dose Vitamin D n=3 Participants Treatment with cholecalciferol 400 IU daily at home. Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks	High Dose Vitamin D n=3 Participants Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic. Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks
Time to Restart Topical Steroids	NA days No subjects restarted topical steroids during the study period.	NA days No subjects restarted topical steroids during the study period.

Adverse Events

Standard Dose Vitamin D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High Dose Vitamin D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yvonne Chiu, MD

Medical College of Wisconsin

Phone: 414-955-2818

Email: ychiu@mcw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place