Key result
L-methylfolate plus methylcobalamin lowers homocysteine by ~6 µmol/L and improves BP in hemodialysis patients.
RCT (n=51)
Open-label
Simple computer-generated randomization
No
This clinical trial demonstrates the benefit of supplementing methylfolate and methylcobalamin to lower blood pressure in ESRD patients with resistant hypertension, suggesting new treatment avenues.
Background End-stage renal disease (ESRD) patients receiving hemodialysis are experiencing a considerable increase in the burden of cardiovascular diseases (CVDs). In this patient population, hypertension is a prevalent modifiable cardiovascular risk factor that is associated with poor prognosis. Resistant hypertension in dialysis patients is challenging to manage since some individuals do not respond to antihypertensive medications or volume control. Hyperhomocysteinemia is common among ESRD patients. “H-type hypertension” or hyperhomocysteinemia-associated hypertension refers to resistant hypertension with elevated cardiovascular risk. The current study examined the efficacy of methylfolate and methylcobalamin supplementation in reducing serum homocysteine levels and improving blood pressure (BP) control in ESRD patients with resistant hypertension on regular hemodialysis. Methods Throughout the study, 51 ESRD patients with resistant hypertension were randomly allocated to receive either daily doses of L-methylfolate 800 mcg and methylcobalamin 1000 mcg capsule (intervention group) or no medication (control group). Serum homocysteine levels were measured twice: at baseline and three months later. In addition, average pre- and post-dialysis blood pressure readings were obtained at baseline, one month, two months, and three months. Results After three months, mean serum homocysteine levels were significantly lower than at the commencement of therapy ( p = 0.035), nonetheless, control patients showed no significant difference. Between-group analysis found a statistically significant difference in the change in homocysteine levels among the two groups ( p = 0.006). Furthermore, the treatment group had statistically significant lower pre- and post-dialysis blood pressure readings. Conclusions A three-month supplementation with a combination of 800 mcg methylfolate and 1000 mcg methylcobalamin showed promise in lowering blood pressure and serum homocysteine levels in ESRD patients with resistant hypertension. These findings require additional exploration in larger studies. Trial registration ClinicalTrials.gov Identifier NCT05807711 registered on 20,230,329.
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Salem et al. (2026) conducted an RCT in End-stage renal disease with resistant hypertension (n=51). L-methylfolate and methylcobalamin vs. No medication (standard of care) was evaluated on Change in serum homocysteine levels at 3 months (MD 6.45, 95% CI 1.106-11.792, p=0.019). A daily combination of 800 mcg L-methylfolate and 1000 mcg methylcobalamin for three months significantly reduced serum homocysteine levels (MD 6.45 µmol/L) and improved blood pressure control compared to standard of care in hemodialysis patients with resistant hypertension.
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