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

Primary Purpose

Vitamin D Deficiency, Vitiligo

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cholecalciferol (vitamin D3)
Phototherapy
Sponsored by
Hallym University Kangnam Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Kangnam Sacred Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study group

Control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Physician global assessment (PGA)
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%.
Physician global assessment (PGA)
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%.
Physician global assessment (PGA)
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%.
Physician global assessment (PGA)
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%.
Physician global assessment (PGA)
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%.
Physician global assessment (PGA)
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%.
Physician global assessment (PGA)
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%.

Full Information

First Posted
May 3, 2022
Last Updated
May 3, 2022
Sponsor
Hallym University Kangnam Sacred Heart Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05364567
Brief Title
Synergistic Effect of Vitamin D Supplementation in Patients With Vitiligo and Vitamin D Deficiency
Official Title
Vitamin D Supplementation in Patients With Vitiligo Induced Additive Effects With Phototherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hallym University Kangnam Sacred Heart Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Vitiligo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
cholecalciferol (vitamin D3)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Phototherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vitiligo Area Scoring Index (VASI)
Description
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
Time Frame
baseline
Title
Vitiligo Area Scoring Index (VASI)
Description
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
Time Frame
1 month
Title
Vitiligo Area Scoring Index (VASI)
Description
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
Time Frame
2 month
Title
Vitiligo Area Scoring Index (VASI)
Description
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
Time Frame
3 month
Title
Vitiligo Area Scoring Index (VASI)
Description
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
Time Frame
4 month
Title
Vitiligo Area Scoring Index (VASI)
Description
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
Time Frame
5 month
Title
Vitiligo Area Scoring Index (VASI)
Description
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Physician global assessment (PGA)
Description
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%.
Time Frame
baseline
Title
Physician global assessment (PGA)
Description
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%.
Time Frame
1 month
Title
Physician global assessment (PGA)
Description
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%.
Time Frame
2 month
Title
Physician global assessment (PGA)
Description
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%.
Time Frame
3 month
Title
Physician global assessment (PGA)
Description
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%.
Time Frame
4 month
Title
Physician global assessment (PGA)
Description
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%.
Time Frame
5 month
Title
Physician global assessment (PGA)
Description
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%.
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Young Chung, M.D., PhD
Organizational Affiliation
Department of Dermatology, Kangnam Sacred Heart Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kangnam Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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