Clinical trial NCT05364567: Synergistic Effect of Vitamin D Supplementation in Patients With Vitiligo and Vitamin D Deficiency
Official title: Vitamin D Supplementation in Patients With Vitiligo Induced Additive Effects With Phototherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Vitiligo
Lead sponsor: Hallym University Kangnam Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants were randomly assigned to two groups: the control group and the study group. Both groups were treated with phototherapy including 308-nm excimer laser or narrowband ultraviolet B. Study group additionally had vitamin D supplementation through the injection of cholecalciferol.
Primary purpose: TREATMENT

Brief summary: This prospective, randomized, controlled study was approved by the Institutional Review Board of Hallym University Kangnam Sacred Heart Hospital (IRB no. 2018-04-017). All study participants consented the study and agreed the written informed consent. All participants who are applicable to the inclusion criteria were randomly assigned to two groups: the control group and the study group. Both groups were treated with phototherapy including 308-nm excimer laser or narrowband ultraviolet B (NB-UVB). Study group had vitamin D supplementation through the injection additionally.


Eligibility criteria: Inclusion Criteria:

1. patients diagnosed with non-segmental vitiligo based on clinical diagnosis.
2. patients who were ≥ 18 years old.
3. patients with lower serum vitamin D level (\<20ng/mL).

Exclusion Criteria:

1. patients taking medicines such as thiazide, diuretics, lithium which can influence the serum vitamin D level.
2. pregnant or lactating women.
3. patients with diseases which can affect kidney such as chronic kidney disease, hyperparathyroidism, or hypoparathyroidism.
4. patients with uncontrolled chronic diseases like diabetes mellitus, hyperlipidemia, hypertension
5. patients whose spot urine calcium level was over 30mg/dL.

Primary outcomes:
measure: Vitiligo Area Scoring Index (VASI)
timeFrame: baseline
measure: Vitiligo Area Scoring Index (VASI)
timeFrame: 1 month
measure: Vitiligo Area Scoring Index (VASI)
timeFrame: 2 month
measure: Vitiligo Area Scoring Index (VASI)
timeFrame: 3 month
measure: Vitiligo Area Scoring Index (VASI)
timeFrame: 4 month
measure: Vitiligo Area Scoring Index (VASI)
timeFrame: 5 month
measure: Vitiligo Area Scoring Index (VASI)
timeFrame: 6 month
Secondary outcomes:
measure: Physician global assessment (PGA)
timeFrame: baseline
measure: Physician global assessment (PGA)
timeFrame: 1 month
measure: Physician global assessment (PGA)
timeFrame: 2 month
measure: Physician global assessment (PGA)
timeFrame: 3 month
measure: Physician global assessment (PGA)
timeFrame: 4 month
measure: Physician global assessment (PGA)
timeFrame: 5 month
measure: Physician global assessment (PGA)
timeFrame: 6 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital
Study officials:
affiliation: Department of Dermatology, Kangnam Sacred Heart Hospital
name: Bo Young Chung, M.D., PhD
role: STUDY_CHAIR
References: