Folic acid supplementation improves cognitive function in participants with cerebral small vascular disease-related cognitive impairment: a randomized controlled trial - 01/12/25

Doi : 10.1016/j.tjpad.2025.100369

Yinyue Liu ^a,^b,^c, Zili Yu ^a,^b,^c, Zhengjun Cai ^d, Li Zhao ^e, Yu Wang ^f, Yajie Guo ^a,^b,^c, Xiaonan Su ^d, Yuli Miao ^e, Bin Yi ^d, Yanhong Wang ^e,^⁎ , Xumei Zhang ^a,^b,^c,^⁎

^a Department of Nutrition and Food Science, School of Public Health, Tianjin Medical University, Tianjin 300070, China

^b Tianjin Key Laboratory of Environment, Nutrition and Public Health, Center for International Collaborative Research on Environment, Nutrition and Public Health, Tianjin Medical University, Tianjin 300070, China

^c Key Laboratory of Prevention and Control of Major Diseases in the Population, Ministry of Education, Tianjin Medical University, Tianjin 300070, China

^d Beijng Silian Pharmaceutical Co., Ltd., Beijing 102609, China

^e Department of Neurosurgery, Affiliated Hospital of Changzhi Institute of TCM, Changzhi City, Shanxi Province 046000, China

^f Department of General Surgery, Affiliated Hospital of Changzhi Institute of TCM, Changzhi City, Shanxi Province 046000, China

^⁎ Corresponding author at: Department of Neurosurgery, Affiliated Hospital of Changzhi Institute of TCM, Changzhi City, Shanxi Province 046000, China. Department of Neurosurgery Affiliated Hospital of Changzhi Institute of TCM Changzhi City Shanxi Province 046000 China ^⁎⁎ Co-corresponding author at: Department of Nutrition and Food Science, School of Public Health, Tianjin Medical University, Tianjin 300070, China. Department of Nutrition and Food Science School of Public Health, Tianjin Medical University Tianjin 300070 China

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Abstract

Background

The potential improvement of cognitive function through folic acid (FA) supplementation in patients with vascular cognitive impairment (VCI) remains unclear, and no randomized controlled trials (RCTs) have been conducted specifically in populations with cerebral small vessel disease-related cognitive impairment (CSVD-CI).

Objective

This study aimed to explore the effects of FA supplementation on cognitive function and angiogenesis-related indicators in patients with CSVD-CI.

Design

Double-blinded, parallel group, randomized controlled trial, with a six-month follow-up period.

Setting

Department of neurology and neurosurgery in Shanxi, China.

Participants

220 CSVD-CI patients.

Interventions

The intervention consisted of FA tablets (0.4 mg/tablet) administered orally at a dose of two tablets daily for six months, while the placebo tablets were identical in appearance and administration but lacked FA.

Measurements

The primary outcome was the Montreal Cognitive Assessment (MoCA) score at six months assessed in the intention-to-treat (ITT) population. Secondary outcomes included Mini-Mental State Examination (MMSE) score, Trail Making Test (TMT), Tinetti Performance Oriented Mobility Assessment (POMA), and five-level EuroQol five-dimensional questionnaire (EQ-5D-5 L).

Results

MoCA and MMSE scores improved significantly in the FA group compared to placebo (both P < 0.05). Additionally, the FA group had statistically significant increases in serum folate and decreases in serum homocysteine (Hcy) (both P < 0.001). Matrix metalloproteinase-9 (MMP-9) expression decreased significantly in the FA group compared with placebo ( P < 0.05).

Conclusions

FA improved cognitive outcomes in CSVD-CI, accompanied by a reduction in serum Hcy levels and MMP-9 expression. Early FA supplementation could help prevent vascular-related cognitive decline in CSVD-CI patients.

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Keywords : Folic acid, Cerebral small vascular disease, Cognition function, Randomized controlled trial, Angiogenesis

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Vol 13 - N° 1

Articolo 100369- gennaio 2026 Ritorno al numero

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