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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05364567
• Other study ID #: 2018-04-017
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2022
• Source: Hallym University Kangnam Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 1, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vitamin D Deficiency
• Vitiligo

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Kangnam Sacred Heart Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Kangnam Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitiligo Area Scoring Index (VASI)	Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.	baseline
Primary	Vitiligo Area Scoring Index (VASI)	Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.	1 month
Primary	Vitiligo Area Scoring Index (VASI)	Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.	2 month
Primary	Vitiligo Area Scoring Index (VASI)	Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.	3 month
Primary	Vitiligo Area Scoring Index (VASI)	Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.	4 month
Primary	Vitiligo Area Scoring Index (VASI)	Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.	5 month
Primary	Vitiligo Area Scoring Index (VASI)	Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.	6 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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