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Completed

NCT Number: NCT05364567

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

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Hypopigmentation Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases Vitiligo

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kangnam Sacred Heart Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Phototherapy

Procedure

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 outcomes

  1. Vitiligo Area Scoring Index (VASI)

    Time frame: baseline

    Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Secondary outcomes

  1. Physician global assessment (PGA)

    Time frame: baseline

    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. Physician global assessment (PGA)

    Time frame: 1 month

    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. Physician global assessment (PGA)

    Time frame: 2 month

    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. Physician global assessment (PGA)

    Time frame: 3 month

    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. Physician global assessment (PGA)

    Time frame: 4 month

    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. Physician global assessment (PGA)

    Time frame: 5 month

    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%.

  7. Physician global assessment (PGA)

    Time frame: 6 month

    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%.

Sponsors and collaborators

Lead sponsor

Hallym University Kangnam Sacred Heart Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
May 6, 2022
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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