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

Not Applicable

Completed

• Conditions: Vitiligo; Vitamin D Deficiency
• Interventions: Drug: cholecalciferol (vitamin D3); Procedure: Phototherapy

• Registration Number: NCT05364567
• Lead Sponsor: Hallym University Kangnam Sacred Heart Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Primary Completion: 2021-06-30
• Status Verified: 2022-05
• Study Completion: 2022-05-01
• Study First Submitted: 2022-05-03
• Study First Submitted QC: 2022-05-03
• Last Update Submitted: 2022-05-03
• Study First Posted: 2022-05-06
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	cholecalciferol (vitamin D3)	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.
Control group	Phototherapy	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.
Study group	Phototherapy	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.

Primary Outcome Measures

Name	Time	Method
Vitiligo Area Scoring Index (VASI)	6 month	Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.

Secondary Outcome Measures

Name	Time	Method
Physician global assessment (PGA)	6 month	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%.

Trial Locations

Locations (1)

Kangnam Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of