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CompletedNCT05149339Updated Dec 8, 2021

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

A Phase 1/2 interventional study of Cholecalciferol 2800 I.U. ml oral drops in Acute Myeloid Leukemia, Vitamin D Deficiency and ADAMTS13, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-08.

Sponsored by Zagazig University · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Mar 2019, registered Nov 2021).
Phase
Phase 1/2
Study type
Interventional
Enrollment
38
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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. 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.

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

I. 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

  1. Patient's consent to share in the study
  2. Patients' age >18 years
  3. Patients with de novo acute myeloid leukemia IV. Exclusion criteria
  1. 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

V. 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:

    1. Complete blood picture ( CBC) using ( Sysmex XS 500)
    2. Peripheral blood film examination
    3. Erythrocyte sedimentation rate ( Westergren tubes )
    4. Prothrombin time, Partial thromboplastin time (Sysmex CS)
    5. C-reactive protein , Liver function tests \& Kidney function tests (Roche Diagnostics, Cobas 8000 c702, Switzerland)
    6. Hepatitis C virus antibody, Hepatitis B virus surface antigen and Human deficiency virus antibody
    7. 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.
  4. Measuring IL-6 and ADAMTS13 using (Luminex Corporation, Luminex® 200 trademark , Austin, USA) before and after induction therapy
  5. 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.

  6. 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).

C. Ethical considerations

  1. The study group will be informed about the nature and the purpose of the study and informed consent will be taken.
  2. The study group will not be exposed to any harm or risk.
  3. Patient's data will be confidential.
02

Conditions studied

  • Acute Myeloid Leukemia
  • Vitamin D Deficiency
  • ADAMTS13
  • Interleukin 6

Keywords

  • ADAMTS13
  • Interleukin 6
  • Vitamin D
  • Acute Myeloid Leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 38 is close to the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Patient's consent to share in the study
  2. Patients' age >18 years
  3. Patients with denovo acute myeloid leukemia

Exclusion criteria

Exclusion Criteria:

  1. 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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • No intervention
    Case subgroup with deficient Vitamin D

    Group with deficient Vitamin D \< 20 ng/mL No treatment for the Vitamin D deficiency

  • Experimental
    Case subgroup with deficient Vitamin D + Vitamin D supplementation

    Group with deficient Vitamin D + Daily oral dose of Cholecalciferol for 28 days for correcting the deficiency

    Drug: Cholecalciferol 2800 I.U. ml oral drops

  • No intervention
    Case subgroup with normal Vitamin D

    Group with normal Vitamin D level \> 20 ng/mL

Interventions

  • DrugCholecalciferol 2800 I.U. ml oral drops

    (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).

06

What researchers measure

Primary outcomes

  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

    Time frame: Oral daily dose for 28 days

Other outcomes

  1. Serum Vitamin D status effect on ADAMTS13 level in AML patients

    Serum Vitamin D (ng/ml) measured using (Roche Diagnostics, Cobas 6000 e 601, Switzerland) on day 1 and day 28 . ADAMTS13 (ng/ml) is measured using (Luminex Corporation, Luminex® 200TM , Austin, USA) on day 1 and day 28 The inter-relation ship will be statistically assessed

    Time frame: 28 days

  2. Serum Vitamin D status effect on IL-6 level in AML patients

    Serum Vitamin D (ng/ml) measured using (Roche Diagnostics, Cobas 6000 e 601, Switzerland) on day 1 and day 28 . IL-6 (PG/ml) is measured using (Luminex Corporation, Luminex® 200TM , Austin, USA) on day 1 and day 28 The inter-relation ship will be statistically assessed

    Time frame: 28 days

07

Study locations

1 site
  • Dina Ashraf Abdelhady
    Cairo, Madinaty 19519, Egypt
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05149339
Lead sponsor
Zagazig University
Responsible party
Dina Ashraf Abdelhady (Principal Investigator, Zagazig University) — Principal investigator
First posted
Dec 8, 2021
Start date
Mar 1, 2019
Primary completion
Feb 1, 2020
Completion
Mar 15, 2021
Last update
Dec 8, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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