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

H

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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