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Effects of Folic Acid and Vitamin B12 Supplementation on Cognitive Impairment and Inflammation in Patients with Alzheimer’s Disease: A Randomized, Single-Blinded, Placebo-Controlled Trial

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The Journal of Prevention of Alzheimer's Disease Aims and scope Submit manuscript

Abstract

Objectives

To evaluate the combined action of folic acid and vitamin B12 supplementation on cognitive performance and inflammation in patients with Alzheimer’s disease (AD).

Design

This was a randomized, single-blind, placebo-controlled trial.

Participants

Patients (n=120) diagnosed clinically as probable AD and in stable condition from Tianjin Key Laboratory of Cerebrovascular and Neurodegenerative Diseases.

Measurements

Individuals were randomly divided into the intervention group (n=60, folic acid 1.2 mg/d + vitamin B12 50 µg/d) and the placebo group (n=60). Cognitive performance, blood folate, vitamin B12, one carbon cycle metabolite, and inflammatory cytokine levels were measured at baseline and after 6 months. The data were analyzed using linear mixed models for repeated measures.

Results

A total of 101 participants (51 in the intervention group and 50 in the placebo group) completed the trial. Folic acid plus vitamin B12 supplementation had a beneficial effect on the MoCA total scores (P=0.029), naming scores (P=0.013), orientation scores (P=0.004), and ADAS-Cog domain score of attention (P=0.008), as compared to those of the control subjects. Moreover, supplementation significantly increased plasma SAM (P<0.001) and SAM/SAH (P<0.001), and significantly decreased the levels of serum Hcy (P<0.001), plasma SAH (P<0.001), and serum TNFα (P<0.001) compared to in the control subjects.

Conclusions

Folic acid and vitamin B12 supplementation showed a positive therapeutic effect in AD patients who were not on a folic acid-fortified diet. The findings of this study help to delineate nutrient intervention as far as public health management for the prevention of dementia is concerned.

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Acknowledgments

The authors thank all the subjects for their participation. The authors declare no potential conflicts of interest relevant to this article. This study was supported by a grant from the National Natural Science Foundation of China (No. 81730091), Tianjin Science and Technology Support Program (No. 15ZCZDSY01040), China Postdoctoral Science Foundation (No. 2017M611179), and the Scientific Program of the Tianjin Education Committee (No. 2016YD20).

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Author notes

  1. These authors contributed equally to work.

Authors and Affiliations

  1. School of Nursing, Tianjin Medical University, Tianjin, China

    H. Chen

  2. Department of Nutrition and Food Science, School of Public Health, Tianjin Medical University, Tianjin, China

    S. Liu, B. Ge, D. Zhou, M. Li, W. Li & Guowei Huang

  3. Department of Neurology, and Tianjin Key Laboratory of Cerebrovascular and Neurodegenerative Diseases, Tianjin Huanhu Hospital, Tianjin, China

    S. Liu & Yong Ji

  4. Department of Epidemiology & Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China

    F. Ma

  5. Tianjin Key Laboratory of Environment, Nutrition, and Public Health, Tianjin, China

    M. Li, W. Li, F. Ma & Guowei Huang

  6. Department of Immunology, Biochemistry and Molecular Biology, 2011 Collaborative Innovation Center of Tianjin for Medical Epigenetics, Tianjin Key Laboratory of Medical Epigenetics, Tianjin Medical University, Tianjin, China

    Z. Liu

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  1. H. Chen
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Corresponding authors

Correspondence to Yong Ji or Guowei Huang.

Ethics declarations

Conflicts of interest: None declared.

Ethical standards: The study was carried out in accordance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice Guidelines.

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Chen, H., Liu, S., Ge, B. et al. Effects of Folic Acid and Vitamin B12 Supplementation on Cognitive Impairment and Inflammation in Patients with Alzheimer’s Disease: A Randomized, Single-Blinded, Placebo-Controlled Trial. J Prev Alzheimers Dis 8, 249–256 (2021). https://doi.org/10.14283/jpad.2021.22

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  • DOI: https://doi.org/10.14283/jpad.2021.22

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