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Acute Myeloid LeukemiaPhase 1/2NCT05149339

Vitamin D Effect on A Disintegrin-like And Metalloprotease Thrombospondin1 Motif 13& Interleukin 6 in Leukemia

A Phase 1/2 study testing Cholecalciferol 2800 I.U. ml oral drops in people with Acute Myeloid Leukemia and Vitamin D Deficiency, run by Zagazig University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Disintegrin-like And Metalloprotease with Thrombospondin type 1 motif 13 (ADAMTS13) deficiency was incriminated in poor prognosis, high probability of serious complications and mortality in acute myeloid leukemia (AML) patients. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
Cholecalciferol 2800 I.U. ml oral drops
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteEgypt
Study dates
1 Mar 2019to 15 Mar 2021
Phase
Phase 1/2
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 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patient's consent to share in the study
  • Patients' age >18 years
  • Patients with denovo acute myeloid leukemia

Who cannot join

  • Patients refusing to share in the study
  • Non-Egyptian patients
  • Patients' age < 18 years
  • Pregnant women
  • Patient's with other malignancies
  • Patients with known congenital thrombotic/ hemorrhagic diseases
  • Patients with Thrombotic Thrombocytopenic Purpura
  • Patients with auto-immune diseases

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Dina Ashraf Abdelhady

    Cairo, Madinaty, 19519

Other trials in Egypt

About this study

Official title: Effect of Vitamin D Status on A Disintegrin-like And Metalloprotease With Thrombospondin Type 1 Motif 13 (ADAMTS13) and Interleukin 6 (IL-6) in Patients With Acute Myeloid Leukemia

A Disintegrin-like And Metalloprotease with Thrombospondin type 1 motif 13 (ADAMTS13) deficiency was incriminated in poor prognosis, high probability of serious complications and mortality in acute myeloid leukemia (AML) patients. Interleukin 6 (IL-6) produced from AML blasts decreases Cluster of differentiation 34 positive(CD34+) cells differentiation, and inhibits the ADAMTS13 actions. Vitamin D "as an Immune-modulator" inhibits the pro-inflammatory cytokines including IL-6. So, supplementation of vitamin D might help down regulation of interleukin-6 production.

Aim of the study To evaluate the potential relation between Vitamin D status, ADAMTS13 and IL-6 in AML patients.

Read more

Objectives

  1. Assess Vitamin D level in AML patients
  2. Assess ADAMTS13 and IL-6 in AML patients
  3. Correlate between Vitamin D level and both of ADAMTS13 and IL-6
Read the detailed description
  1. Setting The study will be carried out in wards of ZAGAZIG University Hospitals II. Subjects The study will be conducted on patients with de novo diagnosis with acute myeloid leukemia III. Inclusion criteria
  2. Patient's consent to share in the study
  3. Patients' age >18 years
  4. Patients with de novo acute myeloid leukemia IV. Exclusion criteria
  5. Patients refusing to share in the study 2. Non-Egyptian patients 3. Patients' age < 18 years 4. Pregnant women 5. Patient's with other malignancies 6. Patients with known congenital thrombotic/ hemorrhagic diseases 7. Patients with Thrombotic Thrombocytopenic Purpura 8. Patients with auto-immune diseases
  6. Study Design This is a Non-randomized control trial I. Sample size up Finding that ADAMTS13 level in AML patients before treatment is 455+_120 ng/ml versus 570+_100 ng/ml after treatment, the sample was calculated to be 30 patients, 15 patients in each group by using (open EPI) at confidence level 95 and power 80 I. Activities Patients attending to ZAGAZIG University Hospitals. Upon agreement, every patient will be asked to provide written informed consent according to the Declaration of Helsinki of 1979.

All patients will be subjected to the following:

  1. Full History taking through an interview
  2. Clinical examination
  3. Laboratory investigations including:
  4. Complete blood picture ( CBC) using ( Sysmex XS 500)
  5. Peripheral blood film examination
  6. Erythrocyte sedimentation rate ( Westergren tubes )
  7. Prothrombin time, Partial thromboplastin time (Sysmex CS)
  8. C-reactive protein , Liver function tests \& Kidney function tests (Roche Diagnostics, Cobas 8000 c702, Switzerland)
  9. Hepatitis C virus antibody, Hepatitis B virus surface antigen and Human deficiency virus antibody
  10. Diagnosis of Acute myeloid leukemia according to clinical findings, CBC, peripheral blood film examination, Bone marrow aspiration, Immunophenotyping (a FACSCAN, Becton Dickinson, San Jose, California, USA)and Cytogenetic analysis.
  11. Measuring IL-6 and ADAMTS13 using (Luminex Corporation, Luminex® 200 trademark , Austin, USA) before and after induction therapy
  12. Measuring Vitamin D serum level using (Roche Diagnostics, Cobas 6000 e 601, Switzerland) before and after induction therapy and vitamin D supplementation based on its deficiency.
  13. Radiology:
  • Echocardiogram
  • Abdominal ultrasound ( If needed)
  • Chest X-Ray II. Data collection Demographic data of the patients will be recorded including name, age, sex and residence. In addition, careful history taking and clinical examination will be done, and data will be registered in special form III. Statistical analysis Our study will be carried on 30 patients with de novo AML. Subjects will be divided into (2) groups as regard treatment of Vitamin D deficiency at the onset of AML diagnosis. Vitamin D therapy will be given to 15 deficient subjects for one month with the recommended doses. All the analytes will be assayed before and after the induction chemotherapy course. Both of these groups will be compared statistically using Statistics program smart solution 22 (SPSS22).

Administrative design:

Approval will be asked from ZAGAZIG University Institutional Review Board (IRB).

  1. Ethical considerations
  2. The study group will be informed about the nature and the purpose of the study and informed consent will be taken.
  3. The study group will not be exposed to any harm or risk.
  4. Patient's data will be confidential.
Being tested
Cholecalciferol 2800 I.U. ml oral drops
Keywords
ADAMTS13, Interleukin 6, Vitamin D, Acute Myeloid Leukemia
Medical subject headings
Leukemia, Myeloid, Acute, Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cholecalciferol 2800 I.U. ml oral dropsDrug

    (Cholecalciferol 2800 I.U. ml) Oral Drops 15 ml. supplied with a dropper.

    • Composition:

    Each 1 ml (= 28 drops) of oral solution contains: Vitamin D3 (Cholecalciferol) 2800 I.U., (each drop contains 100 IU of vitamin D3).

Study groups in NCT05149339
Study groupRoleWhat they receive
Case subgroup with deficient Vitamin DNo interventionGroup with deficient Vitamin D < 20 ng/mL No treatment for the Vitamin D deficiency
Case subgroup with deficient Vitamin D + Vitamin D supplementationExperimentalGroup with deficient Vitamin D + Daily oral dose of Cholecalciferol for 28 days for correcting the deficiency
Receives: Drug: Cholecalciferol 2800 I.U. ml oral drops
Case subgroup with normal Vitamin DNo interventionGroup with normal Vitamin D level > 20 ng/mL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. (Cholecalciferol 2800 I.U. /ml) Oral drops for Vitamin D deficiency correction

    Using 1ml of Cholecalciferol as daily Oral drops for 28 days to correct the Vitamin D deficiency in acute myeloid leukemia patients.

    On day 1;The patient is considered deficient with serum Vitamin D level measuring < 20ng/ml using serum samples operated on (Roche Diagnostics, Cobas 6000 e 601, Switzerland) On using the drug for 28 days and measuring the Vitamin D level on the day 28, Vitamin D is considered to be "corrected" with levels > 20 ng/ml

    Measured: Oral daily dose for 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2021
  2. Study start1 Mar 2019
  3. Primary completion1 Feb 2020
  4. Study completion15 Mar 2021

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05149339
Sponsor's protocol ID
ZU-IRB #5208/13-2-2019
Status last verified
Nov 2021
First submitted
20 Nov 2021
Last updated
8 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Liu C, Zhao L, Zhao J, Xu Q, Song Y, Wang H. Reduced ADAMTS-13 level negatively correlates with inflammation factors in plasma of acute myeloid leukemia patients. Leuk Res. 2017 Feb;53:57-64. doi: 10.1016/j.leukres.2016.12.004. Epub 2016 Dec 20.

    PubMed 28033504

  • Liu C, Han M, Zhao L, Zhu M, Xu Q, Song Y, Wang H. ADAMTS-13 activity reduction in plasma of acute myeloid leukemia predicts poor prognosis after bone marrow transplantation. Hematology. 2019 Dec;24(1):129-133. doi: 10.1080/10245332.2018.1532648. Epub 2018 Oct 16.

    PubMed 30322352

  • Cohen-Hagai K, Rashid G, Einbinder Y, Ohana M, Benchetrit S, Zitman-Gal T. Effect of Vitamin D Status on Von Willebrand Factor and ADAMTS13 in Diabetic Patients on Chronic Hemodialysis. Ann Lab Med. 2017 Mar;37(2):155-158. doi: 10.3343/alm.2017.37.2.155.

    PubMed 28029003

  • Zhang Y, Leung DY, Richers BN, Liu Y, Remigio LK, Riches DW, Goleva E. Vitamin D inhibits monocyte/macrophage proinflammatory cytokine production by targeting MAPK phosphatase-1. J Immunol. 2012 Mar 1;188(5):2127-35. doi: 10.4049/jimmunol.1102412. Epub 2012 Feb 1.

    PubMed 22301548

  • Sun X, Cao ZB, Zhang Y, Ishimi Y, Tabata I, Higuchi M. Association between serum 25-hydroxyvitamin D and inflammatory cytokines in healthy adults. Nutrients. 2014 Jan 2;6(1):221-30. doi: 10.3390/nu6010221.

    PubMed 24451309

  • Sun CF, Zhao X, Han F, Jia Q, Wang L, Lu G, Ding HF. [Changes of ADAMTS13 Activity and TSP1 Level in Patients with Hematologic Malignancies]. Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2016 Oct;24(5):1294-1298. doi: 10.7534/j.issn.1009-2137.2016.05.002. Chinese.

    PubMed 27784345

  • Abdelhady DA, Azab MMM, Alnagar AA, Said N. Effect of vitamin D status on a disintegrin-like and metalloprotease with thrombospondin type 1 motif 13 (ADAMTS13) and interleukin 6 in patients with acute myeloid leukaemia. Eur J Med Res. 2025 Jul 16;30(1):637. doi: 10.1186/s40001-025-02879-8.

    PubMed 40671161

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cholecalciferol 2800 I.U. ml oral drops in people with Acute Myeloid Leukemia and Vitamin D Deficiency, run by Zagazig 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 3 inclusion and 8 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 8 Dec 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

(Cholecalciferol 2800 I.U. /ml) Oral drops for Vitamin D deficiency correction (time frame: Oral daily dose for 28 days). 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 NCT05149339, which also lists 7 linked publications.

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 Dec 2021.

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