Vitamin D DeficiencyNCT05364567
Synergistic Effect of Vitamin D Supplementation in Patients With Vitiligo and Vitamin D Deficiency
A study testing cholecalciferol (vitamin D3) and Phototherapy in people with Vitamin D Deficiency and Vitiligo, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Vitiligo
- What is being tested?
- cholecalciferol (vitamin D3) and Phototherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2018to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Vitamin D Deficiency, Vitiligo
- Being tested
- cholecalciferol (vitamin D3), Phototherapy
- Medical subject headings
- Vitamin D Deficiency, Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PhototherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitiligo Area Scoring Index (VASI)
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
Measured: baseline
Vitiligo Area Scoring Index (VASI)
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
Measured: 1 month
Vitiligo Area Scoring Index (VASI)
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
Measured: 2 month
Vitiligo Area Scoring Index (VASI)
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
Measured: 3 month
Vitiligo Area Scoring Index (VASI)
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
Measured: 4 month
Vitiligo Area Scoring Index (VASI)
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
Measured: 5 month
Vitiligo Area Scoring Index (VASI)
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
Measured: 6 month
Secondary outcomes (7)
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%.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start1 May 2018
- Primary completion30 Jun 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Young Chung, Hallym University Kangnam Sacred Heart Hospital
- Investigators
- Bo Young Chung, M.D., PhD, Study chair, Department of Dermatology, Kangnam Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364567
- Sponsor's protocol ID
- 2018-04-017
- Status last verified
- May 2022
- First submitted
- 3 May 2022
- Last updated
- 6 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation in Patients With Vitiligo Induced Additive Effects With Phototherapy
- ClinicalTrials.gov ID
- NCT05364567
- Acronym / sponsor ID
- 2018-04-017
- Conditions
- Vitamin D Deficiency, Vitiligo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: cholecalciferol (vitamin D3), Procedure: PhototherapyThey 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. |
| Control group | Active comparator | Procedure: PhototherapyThey 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Study group |
| PhototherapyThe 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. | Procedure or surgery | Control group, Study group |
Primary outcome
Vitiligo Area Scoring Index (VASI)
Time frame: baseline
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
Vitiligo Area Scoring Index (VASI)
Time frame: 1 month
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
Vitiligo Area Scoring Index (VASI)
Time frame: 2 month
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
Vitiligo Area Scoring Index (VASI)
Time frame: 3 month
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
Vitiligo Area Scoring Index (VASI)
Time frame: 4 month
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
Vitiligo Area Scoring Index (VASI)
Time frame: 5 month
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
Vitiligo Area Scoring Index (VASI)
Time frame: 6 month
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
7 secondary outcomes
Physician global assessment (PGA)
Time frame: baseline
Physician global assessment (PGA)
Time frame: 1 month
Physician global assessment (PGA)
Time frame: 2 month
Physician global assessment (PGA)
Time frame: 3 month
Physician global assessment (PGA)
Time frame: 4 month
Physician global assessment (PGA)
Time frame: 5 month
Physician global assessment (PGA)
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Young Chung, M.D., PhD study chair
Department of Dermatology, Kangnam Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cholecalciferol (vitamin D3) and Phototherapy in people with Vitamin D Deficiency and Vitiligo, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitiligo Area Scoring Index (VASI) (time frame: baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.