Atopic DermatitisNCT07574242
Effect of vitk2 on Atopic Dermatitis Pediatrics Patients
A study testing vit k2 in people with Atopic Dermatitis, run by October 6 University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- vit k2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Aug 2024to 5 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients aged 6-12 years
- moderate to severe AD according to SCORAD score
Who cannot join
- other cutaneous allergic diseases (urticaria, angioedema, anaphylaxis, contact dermatitis).
- primary immunodeficiency (PID) with cutaneous allergic manifestations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- vit k2, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vit k2Dietary supplement
Vitamin K2 is a fat-soluble vitamin essential for blood clotting, bone health, and heart health, found in animal products and fermented foods.
PlaceboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Placebo |
| vit k2 group | Active comparator | receive oral vitamin k2 45mg once daily for 12 weeks in addition to their conventional treatment Receives: Dietary Supplement: vit k2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the impact of vitamin K2 on the severity of atopic dermatitis, as assessed by the SCORAD score
Measured: 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.
Measured: 3months
Janus kinase (JAK)
Measured: Measured at baseline and after three months
Serum total IgE
Measured: At baseline and after three months
IL-13
Measured: at baseline and after three months
lipid profile
Measured: at baseline and after three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start3 Aug 2024
- Primary completion5 May 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Elsayed, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574242
- Sponsor's protocol ID
- atopic dermatitis
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang M, Miura T, Suzuki S, Chiyotanda M, Tanaka S, Sugiyama K, Kawashima H, Hirano T. 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;44(1):7-17. doi: 10.1248/bpb.b20-00079.
PubMed 33390552
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Vitamin K2 on the Clinical Outcome of Pediatric Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07574242
- Acronym / sponsor ID
- atopic dermatitis
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 3 Aug 2024 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients received placebo orally once daily for 12 weeks in addition to their Conv | Placebo comparator | Other: PlaceboPatients received placebo orally once daily for 12 weeks in addition to their Conv |
| vit k2 group | Active comparator | Dietary Supplement: vit k2receive oral vitamin k2 45mg once daily for 12 weeks in addition to their conventional treatment |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- patients aged 6-12 years
- moderate to severe AD according to SCORAD score
Key exclusion criteria (2 listed)
- other cutaneous allergic diseases (urticaria, angioedema, anaphylaxis, contact dermatitis).
- primary immunodeficiency (PID) with cutaneous allergic manifestations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vit k2Vitamin K2 is a fat-soluble vitamin essential for blood clotting, bone health, and heart health, found in animal products and fermented foods. | Dietary supplement | vit k2 group |
| Placeboplacebo | Other | Patients received placebo orally once daily for 12 weeks in addition to their Conv |
Primary outcome
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
5 secondary outcomes
Examination of the skin for eczema distribution, extent and intensity and Complete systemic examination for different forms of allergic disorder.
Time frame: 3months
Janus kinase (JAK)
Time frame: Measured at baseline and after three months
Serum total IgE
Time frame: At baseline and after three months
IL-13
Time frame: at baseline and after three months
lipid profile
Time frame: at baseline and after three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Results publication: PubMed 33390552Zhang M, Miura T, Suzuki S, Chiyotanda M, Tanaka S, Sugiyama K, Kawashima H, Hirano T. 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;44(1):7-17. doi: 10.1248/bpb.b20-00079.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vit k2 in people with Atopic Dermatitis, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07574242, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.