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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Zagazig University
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- (Cholecalciferol 2800 I.U. /ml) Oral drops for Vitamin D deficiency correction
Study Overview
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
- Assess Vitamin D level in AML patients
- Assess ADAMTS13 and IL-6 in AML patients
- Correlate between Vitamin D level and both of ADAMTS13 and IL-6
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
-
Patient's consent to share in the study
-
Patients' age >18 years
-
Patients with de novo acute myeloid leukemia IV. Exclusion criteria
-
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:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patient's consent to share in the study
- •Patients' age >18 years
- •Patients with denovo acute myeloid leukemia
Exclusion Criteria
- •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
Arms & Interventions
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
Intervention: Cholecalciferol 2800 I.U. ml oral drops (Drug)
Outcomes
Primary Outcomes
(Cholecalciferol 2800 I.U. /ml) Oral drops for Vitamin D deficiency correction
Time Frame: Oral daily dose for 28 days
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Dina Ashraf Abdelhady
Principal Investigator
Zagazig University