Clinical Trials Directory

Trials / Completed

CompletedNCT05364567

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

Vitamin D Supplementation in Patients With Vitiligo Induced Additive Effects With Phototherapy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
29 (actual)
Sponsor
Hallym University Kangnam Sacred Heart Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DRUGcholecalciferol (vitamin D3)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.
PROCEDUREPhototherapyThe 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.

Timeline

Start date
2018-05-01
Primary completion
2021-06-30
Completion
2022-05-01
First posted
2022-05-06
Last updated
2022-05-06

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT05364567. Inclusion in this directory is not an endorsement.