End Stage Renal Disease, Hypertension, Renal
Conditions
Keywords
L-methylfolate, methylcobalamine, homocysteine
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 \> 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
Interventions
DRUGL-Methyl Folate and methylcobalamine
Dietary supplement labeled to contain methylfolate 800 micrograms and methylcobalamine 1000 micrograms
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open-label, single-center, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed