NCT05807711

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 \> 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

• End Stage Renal Disease
• Hypertension, Renal

Interventions

Type	Name	Description
DRUG	L-Methyl Folate and methylcobalamine	Dietary supplement labeled to contain methylfolate 800 micrograms and methylcobalamine 1000 micrograms

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2023-04-11
• Last updated: 2025-01-13

Locations

1 site across 1 country: Egypt