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NCT Number: NCT07574242

Effect of vitk2 on Atopic Dermatitis Pediatrics Patients

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

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Key information

Conditions

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

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

October 6 University

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Placebo

Other

placebo

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 3months

  2. Janus kinase (JAK)

    Time frame: Measured at baseline and after three months

  3. Serum total IgE

    Time frame: At baseline and after three months

  4. IL-13

    Time frame: at baseline and after three months

  5. lipid profile

    Time frame: at baseline and after three months

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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