Effect of vitk2 on Atopic Dermatitis Pediatrics Patients

NCT07574242 | Completed DMC

• 1 other identifier: atopic dermatitis
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• to evaluate the impact of vitamin K2 on the severity of atopic dermatitis, as assessed by the SCORAD score

  at baseline and after 3months

Secondary Outcomes (5)

• Examination of the skin for eczema distribution, extent and intensity and Complete systemic examination for different forms of allergic disorder.

  3months

• Janus kinase (JAK)

  Measured at baseline and after three months

• Serum total IgE

  At baseline and after three months

• IL-13

  at baseline and after three months

• lipid profile

  at baseline and after three months

Study Arms (2)

Patients received placebo orally once daily for 12 weeks in addition to their Conv

PLACEBO COMPARATOR

Patients received placebo orally once daily for 12 weeks in addition to their Conv

Other: Placebo

vit k2 group

ACTIVE COMPARATOR

receive oral vitamin k2 45mg once daily for 12 weeks in addition to their conventional treatment

Dietary Supplement: vit k2

Interventions

vit k2 DIETARY_SUPPLEMENT

Vitamin K2 is a fat-soluble vitamin essential for blood clotting, bone health, and heart health, found in animal products and fermented foods.

vit k2 group

Placebo OTHER

placebo

Patients received placebo orally once daily for 12 weeks in addition to their Conv

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

October 6 University

Giza, Egypt

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Aya elsayed

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: May 7, 2026
• Study Start: August 3, 2024
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: May 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)