Vitamin D Deficiency, Vitiligo
Conditions
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.
Interventions
The study group with vitamin D deficiency was treated with intramuscular injection of 200,000 IU cholecalciferol (Kwangdong Pharmaceutical Co., Seoul, Korea) once at baseline.
PROCEDUREPhototherapy
The phototherapy for treating depigmented areas was by using 308-nm xenon chloride excimer laser (E1, Jetema, Seoul, Korea) or NB-UVB (N-UVB 6000C, Choyang medical, Seongnam, Korea). The initial dose for excimer laser was decided based on the location of depigmented lesion with consideration of the previous results of the phototherapy;40-42 eye = 100mJ/cm2; head, face, ear, neck, axilla = 150mJ/cm2; arm, leg, trunk = 200mJ/cm2; wrist = 250mJ/cm2; elbow, knee = 300mJ/cm2; hand, foot = 400mJ/cm2; finger, toe = 600mJ/cm2; Meanwhile, initial dose for NB-UVB was 400mJ/cm2. If the erythema after laser disappears within 24 hours, the energy dose was increased by 50 mJ/cm2 for each treatment. But if the erythema sustained for 24-48 hours, the energy dose was maintained. If the erythema last longer than 48 hours, the energy dose was decreased by 50-100 mJ/cm2 at each session. If blistering or pain occured, the treatment was omitted until resolution of symptoms.
Sponsors
Hallym University Kangnam Sacred Heart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitiligo Area Scoring Index (VASI) | baseline | Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician global assessment (PGA) | baseline | The PGA score was calculated to check the improvement after treatments. The scale was evaluated on a scale from 0 to 4: 0 = 0%, 1 = 1-25%, 2 = 26-50%, 3 = 51-75%, 4 = 76-100%. |
Countries
South Korea
Outcome results
None listed