Efficacy of L-methylfolate and Methylcobalamine in Treating Hypertension and Its Impact on Serum Homocysteine in Hemodialysis Patients With Resistant Hypertension

Sponsor

Alexandria University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05807711

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease Hypertension, Renal	Drug: L-Methyl Folate and methylcobalamine	Phase 4

Detailed Description

Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University
Agreement from all participants should be taken in this clinical study by assigning an informed consent
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
Patients will be screened for resistant hypertension as determined by the mean of mid-week pre-dialysis BP > 140/90 mm Hg, post-dialysis BP > 130/80 mm Hg over a period of one month.
A blood sample will be collected for homocysteine measurement at baseline
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.
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
As a measurement of the prognosis of elevated homocysteine, we should follow the development of myocardial infarction, stroke and cardiovascular events for 3 months
The appropriate statistical tests will be held according to the study design and parameters to evaluate the significance of the results
Results, conclusion, discussion and recommendations will be given

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

open-label, single-center, randomized controlled trialopen-label, single-center, randomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy of L-methylfolate and Methylcobalamine in Treating Hypertension and Its Impact on Serum Homocysteine in Hemodialysis Patients With Resistant Hypertension

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Experimental: Intervention group Adult end stage renal disease patients maintained on hemodialysis three times a week for at least 3 months with resistant hypertension as determined by pre-dialysis BP > 140/90 mm Hg, post-dialysis BP > 130/80 mm Hg despite the use of three or more drugs. Patients will be assigned to take one tablet daily containing L-methylfolate and methylcobalamine. 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.	Drug: L-Methyl Folate and methylcobalamine Dietary supplement labeled to contain methylfolate 800 micrograms and methylcobalamine 1000 micrograms
No Intervention: No Intervention: Control group Adult end stage renal disease patients maintained on hemodialysis three times a week for at least 3 months with resistant hypertension as determined by pre-dialysis BP > 140/90 mm Hg, post-dialysis BP > 130/80 mm Hg despite the use of three or more drugs. 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.

Arm

Intervention/Treatment

Active Comparator: Experimental: Intervention group

Adult end stage renal disease patients maintained on hemodialysis three times a week for at least 3 months with resistant hypertension as determined by pre-dialysis BP > 140/90 mm Hg, post-dialysis BP > 130/80 mm Hg despite the use of three or more drugs. Patients will be assigned to take one tablet daily containing L-methylfolate and methylcobalamine. 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.

Drug: L-Methyl Folate and methylcobalamine

Dietary supplement labeled to contain methylfolate 800 micrograms and methylcobalamine 1000 micrograms

No Intervention: No Intervention: Control group

Adult end stage renal disease patients maintained on hemodialysis three times a week for at least 3 months with resistant hypertension as determined by pre-dialysis BP > 140/90 mm Hg, post-dialysis BP > 130/80 mm Hg despite the use of three or more drugs. 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.

Outcome Measures

Primary Outcome Measures

average pre-dialysis blood pressure target of ≤ 140/90 mm Hg or an average post-dialysis blood pressure target of ≤ 130/80 mm Hg [3 months]
To achieve an average pre-dialysis blood pressure target of ≤ 140/90 mm Hg or an average post-dialysis blood pressure target of ≤ 130/80 mm Hg. This should be parallel to lowering of serum homocysteine compared to baseline values

Secondary Outcome Measures

myocardial infarction, stroke and cardiovascular events. [3 months]
As a measurement of the prognosis patients will be followed up for the development of myocardial infarction, stroke and cardiovascular events for 3 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult end stage renal disease patients maintained on hemodialysis three times a week for at least 3 months with resistant hypertension as determined by pre-dialysis BP > 140/90 mm Hg, post-dialysis BP > 130/80 mm Hg despite the use of three or more drugs

Exclusion Criteria:

Age > 75 years
Excessive use of alcohol or smoking
Severe hepatic impairment
Acute kidney injury on top of chronic kidney disease
Pregnant females
Allergy or intolerance to any component of the formulation
Medication side effects (methotrexate, theophylline, phenytoin, and cyclosporine) or any drug proven to cause hyperhomocysteinemia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Pharmacy, Alexandria University	Alexandria		Egypt	21521

Sponsors and Collaborators

Alexandria University

Investigators

Principal Investigator: Hanan M El-gowelli, PhD, Professor of Pharmacology & Toxicology, Alexandria University
Principal Investigator: Hesham A Elghoneimy, PhD, Associate Professor of Internal Medicine, Alexandria University
Principal Investigator: Noha A Hamdy, PhD, Assistant Professor of Clinical Pharmacy, Alexandria University
Principal Investigator: Mohamed S Salem, PharmD, Master's student in Clinical Pharmacy and Pharmacy Practice, Alexandria University.