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

NCT05364567 | Completed

• 1 other identifier: 2018-04-017
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Vitiligo

Outcome Measures

Primary Outcomes (7)

• Vitiligo Area Scoring Index (VASI)

  Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.

  baseline

• Vitiligo Area Scoring Index (VASI)

  Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.

  1 month

• Vitiligo Area Scoring Index (VASI)

  Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.

  2 month

• Vitiligo Area Scoring Index (VASI)

  Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.

  3 month

• Vitiligo Area Scoring Index (VASI)

  Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.

  4 month

• Vitiligo Area Scoring Index (VASI)

  Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.

  5 month

• Vitiligo Area Scoring Index (VASI)

  Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.

  6 month

Secondary Outcomes (7)

• Physician global assessment (PGA)

  baseline

• Physician global assessment (PGA)

  1 month

• Physician global assessment (PGA)

  2 month

• Physician global assessment (PGA)

  3 month

• Physician global assessment (PGA)

  4 month

Study Arms (2)

Study group

EXPERIMENTAL

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.

Drug: cholecalciferol (vitamin D3); Procedure: Phototherapy

Control group

ACTIVE COMPARATOR

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.

Procedure: Phototherapy

Interventions

cholecalciferol (vitamin D3) DRUG

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.

Study group

Phototherapy PROCEDURE

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.

Control group; Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hallym University Kangnam Sacred Heart Hospital: lead

Study Sites (1)

Kangnam Sacred Heart Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Vitiligo

Interventions

Cholecalciferol; Phototherapy

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Therapeutics

Study Officials

• Bo Young Chung, M.D., PhD

  Department of Dermatology, Kangnam Sacred Heart Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 6, 2022
• Study Start: May 1, 2018
• Primary Completion: June 30, 2021
• Study Completion: May 1, 2022
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)