Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05807711
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2023-03-29
Brief Title:
Efficacy of L-methylfolate and Methylcobalamine in Treating Hypertension and Elevated Serum Homocysteine in Hemodialysis Patients With Resistant Hypertension
Sponsor:
Alexandria University
Organization:
Alexandria University
Study Overview
Official Title:
Efficacy of L-methylfolate and Methylcobalamine in Treating Hypertension and Elevated Serum Homocysteine in Hemodialysis Patients With Resistant Hypertension
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to evaluate the efficacy of L-methylfolate in combination with methylcobalamine in reducing homocysteine blood levels in hypertensive end-stage renal disease patients on regular hemodialysis and its association with blood pressure control in treatment of resistant hypertension
Detailed Description:
1 Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine Alexandria University
2 Agreement from all participants should be taken in this clinical study by assigning an informed consent
3 Adult end stage renal disease patients maintained on hemodialysis three times a week for at least 3 months with resistant hypertension will be recruited from hemodialysis unit in Alexandria University Hospitals
4 Patients will be screened for resistant hypertension as determined by the mean of mid-week pre-dialysis BP 14090 mm Hg post-dialysis BP 13080 mm Hg over a period of one month
5 A blood sample will be collected for homocysteine measurement at baseline
6 Patients will be randomized using simple randomization technique via computer based program to take one tablet daily containing L-methylfolate and methylcobalamine or no treatment
7 Patients will be followed over a period of 3 months after which blood pressure measurement and blood sampling would be repeated and compared to baseline values
8 As a measurement of the prognosis of elevated homocysteine we should follow the development of myocardial infarction stroke and cardiovascular events for 3 months
9 The appropriate statistical tests will be held according to the study design and parameters to evaluate the significance of the results
10 Results conclusion discussion and recommendations will be given
2 Agreement from all participants should be taken in this clinical study by assigning an informed consent
3 Adult end stage renal disease patients maintained on hemodialysis three times a week for at least 3 months with resistant hypertension will be recruited from hemodialysis unit in Alexandria University Hospitals
4 Patients will be screened for resistant hypertension as determined by the mean of mid-week pre-dialysis BP 14090 mm Hg post-dialysis BP 13080 mm Hg over a period of one month
5 A blood sample will be collected for homocysteine measurement at baseline
6 Patients will be randomized using simple randomization technique via computer based program to take one tablet daily containing L-methylfolate and methylcobalamine or no treatment
7 Patients will be followed over a period of 3 months after which blood pressure measurement and blood sampling would be repeated and compared to baseline values
8 As a measurement of the prognosis of elevated homocysteine we should follow the development of myocardial infarction stroke and cardiovascular events for 3 months
9 The appropriate statistical tests will be held according to the study design and parameters to evaluate the significance of the results
10 Results conclusion discussion and recommendations will be given
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None