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Effect of folic acid intervention on ALT concentration in hypertensives without known hepatic disease: a randomized, double-blind, controlled trial

Abstract

Background/Objectives:

Increasing evidence suggests that altered methionine/folate metabolism may contribute to the development of hepatic injury. We addressed the question of whether folic acid (FA) supplementation can affect serum alanine aminotransferase (ALT) level in hypertensive Chinese adults.

Subjects/Methods:

A total of 480 participants with mild or moderate essential hypertension and without known hepatic disease were randomly assigned to three treatment groups: (1) enalapril only (10 mg, control group); (2) enalapril–FA tablet (10 mg enalapril combined with 0.4 mg of FA, low FA group); and (3) enalapril–FA tablet (10 mg enalapril combined with 0.8 mg of FA, high FA group), once daily for 8 weeks.

Results:

This report included 455 participants in the final analysis according to the principle of intention to treat. We found a significant reduction in ALT level in the high FA group (median (25th percentile, 75th percentile), −0.6 (−6.9, 2.0)IU/l, P=0.0008). Compared with the control group, the high FA group showed a significantly greater ALT-lowering response in men (median ALT ratio (ALT at week 8 to ALT at baseline; 25th percentile, 75th percentile): 0.93 (0.67, 1.06) vs 1.00 (0.91, 1.21), P=0.032), and in participants with elevated ALT (ALT>40 IU/l) at baseline. There was no difference in ALT lowering between the control and the low FA group.

Conclusions:

Compared with treatment using 10 mg of enalapril alone, a daily dose of 10 mg enalapril combined with 0.8 mg of FA showed a beneficial effect on serum ALT level, particularly in men and in participants with elevated (>40 IU/l) ALT.

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Acknowledgements

We gratefully acknowledge the assistance and cooperation of the faculty and staff of the Anhui Medical University and thank all of the participants in our study. This study was conducted in accordance with the current regulations of People‘s Republic of China. The study was supported by Beijing Huaanfo Biomedical Research Center Inc. Beijing, China and in part by a grant from Anhui Provincial Ministry of Education (No. 2002kj174ZC), Anhui Provincial Ministry of Science and Technology, Anhui Medical University Biomedical Institute.

The sponsors did not participate in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript.

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Correspondence to X Xu or Y Huo.

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Contributors: Study concept and design: XQ, JL, YC, ZL, ZZ, JG, DG, JH, YW, FZ, XX, XW, XX, YH. Acquisition of data: JL, YC, ZL, JG, DG, JH, YW, FZ, YH. Analysis of data: XQ, JL, XX, XW, XX, HY. Interpretation of Data: XQ, L, YC, ZL, ZZ, JG, DG, JH, YW, FZ, XX, XW, XX, YH. Drafting and critical review of manuscript for important intellectual content: XQ, JL, YC, ZL, ZZ, JG, DG, JH, YW, FZ, XX, XW, XX, YH.

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Qin, X., Li, J., Cui, Y. et al. Effect of folic acid intervention on ALT concentration in hypertensives without known hepatic disease: a randomized, double-blind, controlled trial. Eur J Clin Nutr 66, 541–548 (2012). https://doi.org/10.1038/ejcn.2011.192

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