CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Cholecalciferol 2800 I.U. ml oral dropsdrug
Likely dose
Cholecalciferol 2800 I.U. ml oral drops 15 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05149339
NCT05149339Phase 2Completed

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

Zagazig University·interventional·Posted Dec 8, 2021·Updated Dec 8, 2021

In Brief

A Phase 2 clinical trial evaluating Cholecalciferol 2800 I.U. ml oral drops for Acute Myeloid Leukemia and 3 related conditions. Completed, enrolled 38 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 8, 2021
Enrollment StartMar 1, 2019
Primary CompletionFeb 1, 2020
Study CompletionMar 15, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.6 years ago

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).