Vitamin D ConcentrationNCT07146555
Vitamin D Satus in Adults With Newly Diagnosed ITP
An observational study of Vitamin D Concentration, run by Assiut University.
Trial summary
Investigator study aims to assess the level of vitamin D in adult patients with newly diagnosed ITP and correlation between its level and treatment respose Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Concentration
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2025to 30 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult patients (>18 years), both male and female, with newly diagnosed immune thrombocytopenia (ITP), recruited from hematology clinics
Inclusion Criteria:1- Adult (age>18 years) 2-Primary ITP. 3-Patients with ITP who received first line steroid therapy.
Exclusion Criteria:1-Age less than18years 2-Secodary ITP 3-Patients with ITP on second line steroid therapy. 4-Chronic renal disease. 5-Chronic liver disease. 6-Malnutrition and malabsorption.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Nourhan Hassan Mohammed Abdelrahiem M Mohamed Abdelrahiem contact
About this study
Official title: Evaluation of Vitamin D Status in Adult Patients With Newly Diagnosed Immune Thrombocytopenia (ITP)
Investigator study aims to assess the level of vitamin D in adult patients with newly diagnosed ITP and correlation between its level and treatment respose
Read the detailed description
ITP is caused by platelet autoantibodies ,cytotoxic T cell and other factors that accelerate platelet destruction and/or inhibit platelet production . In patients with ITP ,antiplatelet autoantibodies frequently appear to be directed against group Ib /IX and group IIb /IIIa expressed on platelets and megakaryocytes ,both primary and secondary ITP may have an overlapping mechanism of thrombocytopenia and exhibit similar signs and symptoms . The mechanism of ITP associated with other infections e.g (varicella ,HIV, HCV)is at least partly related to molecular mimicry ,Where by antibodies occurring in response to infection subsequently recognize platelet antigens .Abnormalities of cell mediated immunity are known to contribute to pathological process .Like many other autoimmune diseases ,ITP has a T helper cell type 1 bias and a reduced activity of T-regulatory cell.
The role of vitamin D and its prohormones in calcium metabolism and bone formation ,as well as their interaction with immune system , have been the focus of an increasing number of studies in recent years . This is not surprising ,as VD receptors are expressed in a variety of tissues , including the brain ,heart ,skin, bowel gonads ,prostate ,breast and immune cells , in additions to bones , kidneys , and parathyroid . A few autoimmune disorders , including rheumatoid arthritis , and insulin -dependent diabetes mellitus ,have been related to VD deficiency in some recent studies .Based on these association , it has been proposed that VD is an extrinsic factor that can influence the prevalence of autoimmune diseases.
The mechanisms underlaying the link between VD and autoimmunity are not completely identified but probably are related to its anti-inflammatory and immune- modulatory functions. VD appears to interact with immune system through its action on the regulation and differentiation of cells like macrophages ,lymphocytes and natural killer cells in addition to interfering in the in vivo and in vitro production of cytokines .The decrease in the interferon Y- synthesis induced by VD may be one of the methods of VD immune modulatory action . New insights regarding the effect of VD3 derivatives as an immunomodulator .Several studies confirm that VD enhances the innate immune response , Whereas it exercises an inhibitory action on the additive immune system by inhibiting the proliferation of type 1 T- helper cells ,increasing the quantity of type 2 T-helper cells ,increasing the quantity of CD4+/CD25+ T-regulator cells, and inhibiting B cell proliferation , generation of B memory cells ,plasma cell differentiation , and immune globulin production .
The purpose of this study was yo assess the association between adult patients diagnosed with immune thrombocytopenia (ITP) and vitamin D level.
- Conditions
- Vitamin D Concentration
- Being tested
- No Interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
| Study group | Role | What they receive |
|---|---|---|
| First group is responder to ttt of ITP | Not described | |
| 3 groups and assess vitamin D level and its relation with bleeding severity and treatment response | Not described Receives: Other: No Interventions | |
| Second group is non responder to ttt of ITP | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Vitamin D Status in Adult Patients with Newly Diagnosed Immune Thrombocytopenia (ITP)
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D ConcentrationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norhan Hassan Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146555
- Sponsor's protocol ID
- Vitamin D in ITP
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vitamin D Status in Adult Patients With Newly Diagnosed Immune Thrombocytopenia (ITP)
- ClinicalTrials.gov ID
- NCT07146555
- Acronym / sponsor ID
- Vitamin D in ITP
- Conditions
- Vitamin D Concentration
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 28 Aug 2025 (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.
Investigator study aims to assess the level of vitamin D in adult patients with newly diagnosed ITP and correlation between its level and treatment respose
Detailed description
ITP is caused by platelet autoantibodies ,cytotoxic T cell and other factors that accelerate platelet destruction and/or inhibit platelet production . In patients with ITP ,antiplatelet autoantibodies frequently appear to be directed against group Ib /IX and group IIb /IIIa expressed on platelets and megakaryocytes ,both primary and secondary ITP may have an overlapping mechanism of thrombocytopenia and exhibit similar signs and symptoms . The mechanism of ITP associated with other infections e.g (varicella ,HIV, HCV)is at least partly related to molecular mimicry ,Where by antibodies occurring in response to infection subsequently recognize platelet antigens .Abnormalities of cell mediated immunity are known to contribute to pathological process .Like many other autoimmune diseases ,ITP has a T helper cell type 1 bias and a reduced activity of T-regulatory cell.
The role of vitamin D and its prohormones in calcium metabolism and bone formation ,as well as their interaction with immune system , have been the focus of an increasing number of studies in recent years . This is not surprising ,as VD receptors are expressed in a variety of tissues , including the brain ,heart ,skin, bowel gonads ,prostate ,breast and immune cells , in additions to bones , kidneys , and parathyroid . A few autoimmune disorders , including rheumatoid arthritis , and insulin -dependent diabetes mellitus ,have been related to VD deficiency in some recent studies .Based on these association , it has been proposed that VD is an extrinsic factor that can influence the prevalence of autoimmune diseases.
The mechanisms underlaying the link between VD and autoimmunity are not completely identified but probably are related to its anti-inflammatory and immune- modulatory functions. VD appears to interact with immune system through its action on the regulation and differentiation of cells like macrophages ,lymphocytes and natural killer cells in addition to interfering in the in vivo and in vitro production of cytokines .The decrease in the interferon Y- synthesis induced by VD may be one of the methods of VD immune modulatory action . New insights regarding the effect of VD3 derivatives as an immunomodulator .Several studies confirm that VD enhances the innate immune response , Whereas it exercises an inhibitory action on the additive immune system by inhibiting the proliferation of type 1 T- helper cells ,increasing the quantity of type 2 T-helper cells ,increasing the quantity of CD4+/CD25+ T-regulator cells, and inhibiting B cell proliferation , generation of B memory cells ,plasma cell differentiation , and immune globulin production .
The purpose of this study was yo assess the association between adult patients diagnosed with immune thrombocytopenia (ITP) and vitamin D level.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| First group is responder to ttt of ITP | – | – |
| 3 groups and assess vitamin D level and its relation with bleeding severity and treatment response | – | Other: No Interventions |
| Second group is non responder to ttt of ITP | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult patients (>18 years), both male and female, with newly diagnosed immune thrombocytopenia (ITP), recruited from hematology clinics
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 |
|---|---|---|
| No Interventions | Other | 3 groups and assess vitamin D level and its relation with bleeding severity and treatment response |
Primary outcome
Evaluation of Vitamin D Status in Adult Patients with Newly Diagnosed Immune Thrombocytopenia (ITP)
Time frame: Baseline to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Yes
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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.
Nourhan Hassan Mohammed Abdelrahiem M Mohamed Abdelrahiem contact
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Concentration, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nourhan Hassan Mohammed Abdelrahiem M Mohamed Abdelrahiem (01090478865, Norhan.17289928@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Vitamin D Status in Adult Patients with Newly Diagnosed Immune Thrombocytopenia (ITP) (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2025.