NCT05149339

Brief 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. 1.Assess Vitamin D level in AML patients
  2. 2.Assess ADAMTS13 and IL-6 in AML patients
  3. 3.Correlate between Vitamin D level and both of ADAMTS13 and IL-6

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
Last Updated

December 8, 2021

Status Verified

November 1, 2021

Enrollment Period

11 months

First QC Date

November 20, 2021

Last Update Submit

November 25, 2021

Conditions

Acute Myeloid LeukemiaVitamin D DeficiencyADAMTS13Interleukin 6

Keywords

ADAMTS13Interleukin 6Vitamin DAcute Myeloid Leukemia

Outcome Measures

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

    Oral daily dose for 28 days

Other Outcomes (2)

  • Serum Vitamin D status effect on ADAMTS13 level in AML patients

    28 days

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

    28 days

Study Arms (3)

Case subgroup with deficient Vitamin D

NO INTERVENTION

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

Case subgroup with deficient Vitamin D + Vitamin D supplementation

EXPERIMENTAL

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

Case subgroup with normal Vitamin D

NO INTERVENTION

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

Interventions

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).

Case subgroup with deficient Vitamin D + Vitamin D supplementation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dina Ashraf Abdelhady

Cairo, Madinaty, 19519, Egypt

Location

Related Publications (7)

  • 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.

    PMID: 28033504RESULT

  • 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.

    PMID: 30322352RESULT

  • 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.

    PMID: 28029003RESULT

  • 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.

    PMID: 22301548RESULT

  • 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.

    PMID: 24451309RESULT

  • 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.

    PMID: 27784345RESULT

  • 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.

    PMID: 40671161DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteVitamin D Deficiency

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2021

First Posted

December 8, 2021

Study Start

March 1, 2019

Primary Completion

February 1, 2020

Study Completion

March 15, 2021

Last Updated

December 8, 2021

Record last verified: 2021-11

Locations

EG(1)