Randomized controlled double-blind trial of the effect of vitamin D3 (cholecalciferol) supplementation for vitiligo patients.

JRCT ID: jRCTs021200041

Registered date:12/03/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Vitiligo
• Date of first enrollment: 30/09/2021
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Taking vitamin D3 capsules (5,000 IU) or placebo capsules once a day for 5 months for vitiligo patients.

Outcome(s)

• Primary Outcome: Systemic efficacy endpoints; Change of Vitiligo Assessment Scoring Index (VASI).

Secondary Outcome

Local efficacy endpoints; Evaluation of the degree of improvement of vitiligo lesions from photographed images (at registration, after 5 months).
Safety Information; Adverse Events and abnormal inspection value (at registration, after 5 months, after 9 months).
Serum 25(OH)D3 concentration; at registration, after 5 months, after 9 months.
Efficacy endpoints; Evaluation of the degree of improvement of vitiligo from systemic efficacy and local efficacy after 9 months).

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

(1) Patients who are between the ages of 20 and 80 at the time of registration (regardless of gender, regardless of inpatients or outpatients but mainly recruiting from outpatients) and who have given written informed consent by themselves.
(2) Patients who have been confirmed as vitiligo vulgaris according to the Japanese Dermatological Association guidelines and diagnostic guide.
(3) Patients who are refractory to treatment with standard topical drugs for the past 6 months or more and are judged to be intractable.
(4) Patients who have no abnormalities in the blood Ca, P, PTH, and other laboratory values that may affect blood vitamin D levels due to screening tests at the first visit that violate the exclusion criteria
(5) Patients who have no abnormal values that conflict the exclusion criteria for liver and kidney functions related to vitamin D metabolism.
(6) There is no complication of systemic disease specified in the exclusion criteria.
(7) Patients whose investigator (assignment) judges that research participation in this study is appropriate

Exclude criteria

(1) Subjects who are taking drugs and supplements containing vitamin D.
(2) Subjects with serum calcium 8 mg / dL or lower, 10 mg / dL or higher.
(3) Subjects with serum P value 2.5 mg / dL or lower, or 4.5 mg / dL or higher.
(4) Subjects with PTH value outside the standard value. (Standard value of PTH-intact: 10-65 pg / mL)
(5) Hepatic dysfunction; Subjects with AST or ALT more than 2.5 times the standard value. Subjects with g-GTP more than 3 times the standard value.
(6) Renal dysfunction; Subjects with serum creatinine level >=1.2 mg / dL or eGFR <=50.
(7) Pregnant women, women who has possibility of pregnant, woman within 28 days after childbirth, or woman who in breastfeeding.
(8) Minors younger than 20 years, subjects aged 71 years or older (at the time of registration).
(9) Subjects who are suffering from osteoporosis. Subjects who are judged that it is desirable to give priority to treatment for osteoporosis.
(10) Subjects who are suffering from rickets and hypocalcemia to be treated.
(11) Subjects who have mental illness or psychiatric symptoms and are judged to be difficult to participate in the study.

Related Information

• Primary Sponsor: Suzuki Tamio
• Source(s) of Monetary Support: Kao Corporation