Folic Acid Prevents the Initial Occurrence of Sporadic Colorectal Adenoma in Chinese Older than 50 Years of Age: A Randomized Clinical Trial

Cancer Prevention Research
Q1
May 2013
Citations:48
Influential Citations:2
Interventional (Human) Studies
82
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Methods
Prospective, randomized, open-label, multicenter trial across five centers in China. Participants aged 50–80 years with no prior colorectal adenomas, confirmed by complete colonoscopy within the past 5 years. After a 2-week run-in, participants were randomized 1:1 to receive folic acid supplementation or no folic acid. Colonoscopy at baseline and after 3 years; plasma folate measured at baseline and end of follow-up; analyses included intention-to-treat and per-protocol.
Intervention
1 mg/day folic acid, oral supplement, for 3 years.
Results
Folic acid supplementation reduced 3-year CRA incidence (64/430, 14.9%) vs control (132/430, 30.7%), RR 0.49, 95% CI 0.37-0.63; P<0.01. Left-sided adenomas decreased (42 vs 78; RR 0.54). Advanced adenomas decreased (8 vs 22; RR 0.36). Right-sided and multiple adenomas showed no significant differences. Baseline plasma folate inversely related to CRA risk; those with low baseline folate may benefit more from supplementation, supporting individualized folate strategies. Conclusion: 1 mg/day folic acid for 3 years could reduce CRA incidence in adults over 50 without prior adenomas, especially left-sided and advanced disease; plasma-folate-guided personalized supplementation is suggested.
Limitations
Open-label design without blinding; potential residual confounding and bias; run-in exclusions and losses to follow-up may affect results; generalizability limited to older Chinese adults; colonoscopy quality and adherence factors could influence detection.

Abstract

Colorectal adenoma (CRA) is the precursor lesion of colorectal cancer (CRC). Several agents have been shown to be effective in the chemoprevention of CRA recurrence, but there has been little research on its primary prevention. Participants older tha...