Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508099
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Vitamin A and D Supplementation in Allogeneic HCT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Study of Vitamin A and D Prophylaxis Before Allogeneic Related and Unrelated Hematopoietic Stem Cell Transplantation
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VitaStem
Brief Summary:
The therapy under investigation is the addition of 300 000 IU of vitamin A and 100 000 IU of vitamin D before conditioning The study will include patients with malignant diseases in hematologic response with indications for allogeneic transplantation with matched related or matched unrelated donor
Detailed Description:
Currently there is an emerging evidence of gut microbiota role in major complications of HCT including GVHD oral mucositis infectious complications due to multi-drug resistant bacteria in the gut Early exhaustion of most intestinal bacterial phyla after HSCT is documented in many studies This effect of intensive anti-infectious therapy is well known Most authors explain the disruption of intestinal microbiota by massive antibiotic treatment in order to prevent infectious complications due to immune deficiency following HCT Early decrease in anaerobic bacteria phylum Firmicutes is revealed in many studies with subsequent recovery of these bacterial populations within next 2 months This time dynamics is in accordance with reported data on depletion of certain anaerobic gut bacteria eg Ruminococcus Faecalibacterium spp Roseburia Blautia post-transplant being associated with severe complications in HCT patients These results are in accordance with severe posttransplant dysbiosis at different mucosal sites post-HCT as shown elsewhere by routine bacteriology techniques The metabolism of bacteria with positive effect on GVHD includes both vitamin D and vitamin A It was demonstrated that Ruminococcus abundance is dependent on vitamin A and D intake Another bacteria genera Faecalibacterium prausnitzii which is also reported to produce butyrate and reduce GVHD is also dependent on abundance of vitamin A The big phylum Firmicutes are also dependant on vitamin D and their abundance is reported to be associated with lower incidence of immune complications and suppression of antibiotic-resistant strains To summarize the idea of the study is based on modulation of gut microbiota which in term may result in lower incidence of GVHD and toxic complications of HCT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None