Effect of vitk2 on Atopic Dermatitis Pediatrics Patients

May 3, 2026 updated by: Aya Elsayed, October 6 University

Evaluation of the Effect of Vitamin K2 on the Clinical Outcome of Pediatric Patients With Atopic Dermatitis

investigate the effectiveness and safety of adding vitamin K2 at a dose of 45 mg/day for 12 weeks to conventional therapy for paediatric patients with moderate to severe atopic dermatitis according to SCORAD score

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a multicentre, prospective, blind randomized. patients are randomized to either receive their conventional therapy alone or by adding vitamin k2 for 12 weeks. The primary outcome was to evaluate the impact of vitamin K2 on the severity of atopic dermatitis, as assessed by the SCORAD score at 12 weeks compared to baseline.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • October 6 University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients aged 6-12 years
  • moderate to severe AD according to SCORAD score

Exclusion Criteria:

  • other cutaneous allergic diseases (urticaria, angioedema, anaphylaxis, contact dermatitis).
  • primary immunodeficiency (PID) with cutaneous allergic manifestations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Patients received placebo orally once daily for 12 weeks in addition to their Conv
Other: Placebo
placebo
Active Comparator: vit k2 group
receive oral vitamin k2 45mg once daily for 12 weeks in addition to their conventional treatment
Dietary supplement: vit k2
Vitamin K2 is a fat-soluble vitamin essential for blood clotting, bone health, and heart health, found in animal products and fermented foods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
to evaluate the impact of vitamin K2 on the severity of atopic dermatitis, as assessed by the SCORAD score
Time Frame: at baseline and after 3months
at baseline and after 3months

Secondary Outcome Measures

Outcome Measure
Time Frame
Examination of the skin for eczema distribution, extent and intensity and Complete systemic examination for different forms of allergic disorder.
Time Frame: 3months
3months
Janus kinase (JAK)
Time Frame: Measured at baseline and after three months
Measured at baseline and after three months
Serum total IgE
Time Frame: At baseline and after three months
At baseline and after three months
IL-13
Time Frame: at baseline and after three months
at baseline and after three months
lipid profile
Time Frame: at baseline and after three months
at baseline and after three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

October 6 University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Zhang M, Miura T, Suzuki S, Chiyotanda M, Tanaka S, Sugiyama K, et al. Vitamin K2 Suppresses Proliferation and Inflammatory Cytokine Production in Mitogen-Activated Lymphocytes of Atopic Dermatitis Patients through the Inhibition of Mitogen-Activated Protein Kinases. Biol Pharm Bull. 2021 Jan 1;44(1):7-17.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2024

Primary Completion (Actual)

May 5, 2025

Study Completion (Actual)

May 5, 2025

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

May 3, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • atopic dermatitis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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