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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Intervention group | Active Comparator | 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. |
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| No Intervention: Control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-Methyl Folate and methylcobalamine | Drug | Dietary supplement labeled to contain methylfolate 800 micrograms and methylcobalamine 1000 micrograms |
|
| Measure | Description | Time Frame |
|---|---|---|
| average pre-dialysis blood pressure target of ≤ 140/90 mm Hg or an average post-dialysis blood pressure target of ≤ 130/80 mm Hg | 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| myocardial infarction, stroke and cardiovascular events. | As a measurement of the prognosis patients will be followed up for the development of myocardial infarction, stroke and cardiovascular events for 3 months. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Associate Professor of Clinical Pharmacy, Alexandria University | Principal Investigator |
| Mohamed S Salem, PharmD | Master's student in Clinical Pharmacy and Pharmacy Practice, Alexandria University. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Pharmacy, Alexandria University | Alexandria | Alexandria Governorate | 21521 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27847909 | Background | Li J, Jiang S, Zhang Y, Tang G, Wang Y, Mao G, Li Z, Xu X, Wang B, Huo Y. H-type hypertension and risk of stroke in chinese adults: A prospective, nested case-control study. J Transl Int Med. 2015 Oct-Dec;3(4):171-178. doi: 10.1515/jtim-2015-0027. Epub 2015 Dec 30. | |
| 18587236 | Result | Cianciolo G, La Manna G, Coli L, Donati G, D'Addio F, Persici E, Comai G, Wratten M, Dormi A, Mantovani V, Grossi G, Stefoni S. 5-methyltetrahydrofolate administration is associated with prolonged survival and reduced inflammation in ESRD patients. Am J Nephrol. 2008;28(6):941-8. doi: 10.1159/000142363. Epub 2008 Jun 30. |
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open-label, single-center, randomized controlled trial
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| 11562419 | Result | Friedman AN, Bostom AG, Selhub J, Levey AS, Rosenberg IH. The kidney and homocysteine metabolism. J Am Soc Nephrol. 2001 Oct;12(10):2181-2189. doi: 10.1681/ASN.V12102181. |
| 15385656 | Result | Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031. |
| 41580678 | Derived | Salem MS, Hamdy NA, Elghoneimy HA, El Gowelli HM. Efficacy of L-methylfolate and methylcobalamin in treating resistant hypertension associated with elevated serum homocysteine in hemodialysis patients. BMC Nephrol. 2026 Jan 24;27(1):123. doi: 10.1186/s12882-025-04726-8. |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D006977 | Hypertension, Renal |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C005984 | 5-methyltetrahydrofolate |
| C019476 | mecobalamin |
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