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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- (Cholecalciferol 2800 I.U. /ml) Oral drops for Vitamin D deficiency correction
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient's consent to share in the study
- •Patients' age >18 years
- •Patients with denovo acute myeloid leukemia
排除标准
- •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
研究组 & 干预措施
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
干预措施: Cholecalciferol 2800 I.U. ml oral drops (Drug)
结局指标
主要结局
(Cholecalciferol 2800 I.U. /ml) Oral drops for Vitamin D deficiency correction
时间窗: 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
次要结局
未报告次要终点
研究者
Dina Ashraf Abdelhady
Principal Investigator
Zagazig University