Synergistic Effect of Vitamin D Supplementation in Patients With Vitiligo and Vitamin D Deficiency

Hallym University Kangnam Sacred Heart Hospital

Status: Completed

Conditions: Vitiligo; Vitamin D Deficiency

Treatments: Drug: cholecalciferol (vitamin D3); Procedure: Phototherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05364567

2018-04-017

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Study group

Experimental group

Description:

They were treated with phototherapy including 308-nm excimer laser or narrowband ultraviolet B (NB-UVB). They had vitamin D supplementation through the injection of cholecalciferol additionally. 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. Total study period was 6 months and the clinical assessments with checking adverse events were conducted every month.

Treatment:

Drug: cholecalciferol (vitamin D3)

Procedure: Phototherapy

Control group

Active Comparator group

Description:

They were treated with phototherapy including 308-nm excimer laser or narrowband ultraviolet B (NB-UVB). Total study period was 6 months and the clinical assessments with checking adverse events were conducted every month.

Treatment:

Procedure: Phototherapy