NCT03874975

Brief Summary

To compare the results of vitamin D plus UVB in treatment of psoriasis vulgaris with the results of UVB alone to study the relation between serum vitamin D and PASI score before and after treatment.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Apr 2019

Shorter than P25 for early_phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

Same day

First QC Date

March 6, 2019

Last Update Submit

March 13, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • measure serum vitamin D before and after treatment in psoriatic patients

    A 3ml blood sample will be collected from the patients, then allowed to clot for 10 minutes and then centrifuged . Group 1: 20 patients under oral vitamin D therapy ( oral alpha one for 3 months o.25 microgram / day ) in combination with narrow band UVB settings (twice/week) Group 2 : 20 patients under narrow band UVB therapy only . c) We evaluate psoriatic patient by PASI score before and after treatment : ) measurment vitamin D level before and after treatment.

    1 year

Secondary Outcomes (1)

  • We evaluate psoriatic patient by PASI score before and after treatment :

    1 year

Interventions

vitamin D and UVB versus UVB alone in psoriatic patients and evaluate patients by PASI score before and after treatment and measure serum vitamin D before and after treatment

Also known as: narrow band UVB

Eligibility Criteria

Age10 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • : patients from 10 to 60 diagnosed to have psoriasis vulgaris

You may not qualify if:

  • concomitant chronic inflammatory disease or malignancy.
  • pregnant and lactating women.
  • renal dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

meryhan abdelazeem, master

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 40 patients divided into two groups : group 1 :20 patients underoral vitamin D and UVB group 2 : 20 patients under uvb alone in psoriatic patients
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal Investigator

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 14, 2019

Study Start

April 1, 2019

Primary Completion

April 1, 2019

Study Completion

April 1, 2020

Last Updated

March 14, 2019

Record last verified: 2019-03