A study of vitamin D added to standard treatment for people with alopecia areata

ISRCTN ISRCTN24123156
DOI https://doi.org/10.1186/ISRCTN24123156
Sponsors University of Jeddah, Jordanian Universities Network (Jordan)
Funders University of jeddah, King Hussein Cancer Center
Submission date
05/08/2026
Registration date
06/08/2026
Last edited
06/08/2026
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Asem Aldebei
Principal investigator, Public, Scientific

-
Amman
-
Jordan

ORCiD logo 0009-0009-1497-2461
+962 790872373
asemdebie83@gmail.com
Dr Yara Hammouri
Public

-
Amman
-
Jordan

ORCiD logo 0009-0007-0558-8471
+962 777797718
Yarashammouri@hotmail.com
Dr Hussam Al Issa
Public, Scientific

-
Amman
-
Jordan

ORCiD logo 0009-0008-2000-3440
Drhussamalissa@gmail.com
Dr Alaa Al-falahat
Public, Scientific

-
Amman
-
Jordan

ORCiD logo 0009-0004-5897-1771
alaafalahatwp@gmail.com
Dr Malik Albattah
Public, Scientific

-
Amman
-
Jordan

ORCiD logo 0009-0003-8669-4866
malikalbattah@gmail.com
Dr Ahmed AlHasan
Public, Principal investigator, Scientific

-
Riyadh
-
Saudi Arabia

ORCiD logo 0000-0002-1911-3625
+966 533438383
1408903@uj.edu.sa

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingBlinded (masking used)
ControlActive
AssignmentParallel
PurposeTreatment
Scientific titleVitamin D as an adjunct to janus kinase inhibitors for alopecia areata: a randomized controlled trial
Study acronymVIT-JAK-AA
Study objectives To evaluate whether adjunctive vitamin D supplementation improves the efficacy of Janus kinase (JAK) inhibitor therapy in patients with alopecia areata by assessing hair regrowth, quality of life, safety, and serum vitamin D levels over a 12-month follow-up period.
Ethics approval(s)

Approved 18/12/2024, Institutional Review Board (IRB) committee in King Hussein Hospital, Jordanian Royal Medical Services (-, Amman, 56666, Jordan; +962 777797718; Mraghda656@gmail.com), ref: 1964 (approval no:18/2024)

Health condition(s) or problem(s) studiedAlopecia areata (including alopecia totalis and alopecia universalis)
InterventionParticipants are randomly allocated in a 1:1 ratio to one of two parallel treatment groups. Randomisation was performed using a computer-generated block randomisation sequence in a 1:1 ratio. Allocation concealment was achieved through a centralised electronic randomisation system, preventing foreknowledge of group assignment prior to enrolment.

Intervention group: Janus kinase (JAK) inhibitor therapy plus oral vitamin D3 (cholecalciferol) supplementation administered according to the study protocol for 12 months.

Control group: Janus kinase (JAK) inhibitor therapy alone for 12 months, with identical clinical follow-up and assessments.
Intervention typeDrug
PhasePhase IV
Drug / device / biological / vaccine name(s)Baricitinib, tofacitinib, and cholecalciferol (vitamin D3)
Primary outcome measure(s)
  1. Severity of alopecia measured using Severity of Alopecia Tool (SALT) at baseline, 6 months, and 12 months
Key secondary outcome measure(s)
  1. Safety and treatment-related adverse events measured using clinical assessment, adverse event reporting, and laboratory monitoring (CBC, liver function tests, lipid profile, calcium, and serum vitamin D). at throughout the 12-month study period
  2. Quality of life measured using Dermatology Life Quality Index (DLQI) at baseline, 6 months, and 12 months
  3. Serum 25-hydroxyvitamin D level measured using nmol/L at baseline, 6 months, and 12 months
  4. Treatment adherence measured using patient adherence assessed by treatment compliance and follow-up attendance at throughout the 12-month study period
Completion date05/08/2026

Eligibility

Participant type(s)
Age groupAdult
Lower age limit18 Years
Upper age limit60 Years
SexAll
Target sample size at registration73
Total final enrolment73
Key inclusion criteria1. Adults aged 18 years or older
2. Clinical diagnosis of alopecia areata, alopecia totalis, or alopecia universalis
3. No treatment with Janus kinase inhibitors during the previous 6 months
4. Able and willing to provide informed consent and comply with all study visits and procedures
Key exclusion criteria1. Pregnancy or breastfeeding
2. Active autoimmune disease contraindicating Janus kinase inhibitor therapy
3. Positive tuberculosis screening (Quantiferon)
4. Positive hepatitis screening
5. Abnormal baseline laboratory findings including LDL >150 mg/dL, triglycerides >200 mg/dL, total cholesterol >200 mg/dL, AST >37 U/L, or ALT >37 U/L
6. Hypercalcemia
7. Vitamin D toxicity
8. Recent malignancy
9. Active systemic infection
10. Current systemic immunosuppressive therapy
11. Known secondary vitamin D deficiency
Date of first enrolment05/12/2024
Date of final enrolment01/01/2026

Locations

Countries of recruitment

  • Jordan

Study participating centre

Royal Medical Services – King Hussein Medical Center
Amman
Amman
66666
Jordan

Results and Publications

Individual participant data (IPD) Intention to shareNo

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version 1.0 18/12/2024 06/08/2026 No No

Additional files

50046 Study Protocol v1.0 18Dec2024.pdf
Protocol file

Editorial Notes

06/08/2026: Trial's existence confirmed by Institutional Review Board (IRB) committee in King Hussein Hospital, Jordanian Royal Medical Services.

BMC - Part of Springer Nature Springer Nature