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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Vitiligo
• Intervention / Treatment: Drug: cholecalciferol (vitamin D3); Procedure: Phototherapy

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • KangNam Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; 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); 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.; Procedure: Phototherapy; 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.
Active Comparator: Control group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	baseline
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%.	1 month
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%.	2 month
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%.	3 month
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%.	4 month
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%.	5 month
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%.	6 month

Collaborators and Investigators

• Sponsor: Hallym University Kangnam Sacred Heart Hospital
• Investigators: Study Chair: Bo Young Chung, M.D., PhD, Department of Dermatology, Kangnam Sacred Heart Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Pigmentation Disorders; Hypopigmentation; Vitamin D Deficiency; Vitiligo; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 2018-04-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No