Efficacy of L-methylfolate and Methylcobalamine in Treating Resistant Hypertension Associated with Elevated Serum Homocysteine in Hemodialysis Patients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-05-01

Brief Summary

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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

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Detailed Description

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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 \> 140/90 mm Hg, post-dialysis BP \> 130/80 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

Conditions

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End Stage Renal Disease Hypertension, Renal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

open-label, single-center, randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

L-Methyl Folate and methylcobalamine

Intervention Type DRUG

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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L-Methyl Folate and methylcobalamine

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No