Randomized clinical trial of folate supplementation in patients with peripheral arterial disease

Br J Surg. 2009 Sep;96(9):990-8. doi: 10.1002/bjs.6670.

Abstract

Background: The aim was to determine whether folate supplementation improved arterial function in patients with peripheral arterial disease (PAD).

Methods: Individuals with PAD were randomly assigned to receive 400 microg folic acid (45 patients) or 5-methyltetrahydrofolate (5-MTHF) (48) daily, or placebo (40) for 16 weeks. Primary endpoints were changes in plasma total homocysteine (tHcy), ankle : brachial pressure index (ABPI) and pulse wave velocity (PWV). Secondary outcomes were changes in plasma inflammatory markers.

Results: Plasma tHcy was significantly reduced in folic acid and 5-MTHF groups compared with controls: median difference: - 2.12 (95 per cent confidence interval - 3.70 to - 0.75) micromol/l (P = 0.002) and - 2.07 (-3.48 to - 0.54) micromol/l (P = 0.007) respectively. ABPI improved significantly: median difference 0.07 (0.04 to 0.11) (P < 0.001) and 0.05 (0.01 to 0.10) (P = 0.009) respectively. Brachial-knee PWV (bk-PWV) decreased significantly in individuals receiving 5-MTHF and tended to be reduced in those taking folic acid compared with controls: median difference: - 1.10 (-2.20 to - 0.20) m/s (P = 0.011) and - 0.90 (-2.10 to 0.00) m/s (P = 0.051) respectively. Plasma levels of inflammatory markers were not affected.

Conclusion: Folate administration reduced plasma homocysteine, and slightly improved ABPI and bk-PWV.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Ankle Brachial Index
  • Blood Flow Velocity / drug effects
  • Cardiovascular Agents / administration & dosage*
  • Dietary Supplements
  • Double-Blind Method
  • Female
  • Folic Acid / administration & dosage*
  • Homocysteine / metabolism
  • Humans
  • Intermittent Claudication / blood
  • Intermittent Claudication / diet therapy*
  • Intermittent Claudication / physiopathology
  • Male
  • Middle Aged
  • Tetrahydrofolates / administration & dosage*
  • Treatment Outcome

Substances

  • Cardiovascular Agents
  • Tetrahydrofolates
  • Homocysteine
  • Folic Acid
  • 5-methyltetrahydrofolate