title: Effect of supplementation during pregnancy with L-arginine and antioxidant vitamins in medical food on pre-eclampsia in high risk population: randomised controlled trial.
abstract: OBJECTIVE
  To test the hypothesis that a relative deficiency in L-arginine, the substrate for synthesis of the vasodilatory gas nitric oxide, may be associated with the development of pre-eclampsia in a population at high risk.
  
  
  METHODS
  Randomised, blinded, placebo controlled clinical trial.
  
  
  METHODS
  Tertiary public hospital in Mexico City.
  
  
  METHODS
  Pregnant women with a history of a previous pregnancy complicated by pre-eclampsia, or pre-eclampsia in a first degree relative, and deemed to be at increased risk of recurrence of the disease were studied from week 14-32 of gestation and followed until delivery.
  
  
  METHODS
  Supplementation with a medical food-bars containing L-arginine plus antioxidant vitamins, antioxidant vitamins alone, or placebo-during pregnancy.
  
  
  METHODS
  Development of pre-eclampsia/eclampsia.
  
  
  RESULTS
  222 women were allocated to the placebo group, 228 received L-arginine plus antioxidant vitamins, and 222 received antioxidant vitamins alone. Women had 4-8 prenatal visits while receiving the bars. The incidence of pre-eclampsia was reduced significantly (χ(2) = 19.41; P < 0.001) in women randomised to L-arginine plus antioxidant vitamins compared with placebo (absolute risk reduction 0.17 (95% confidence interval 0.12 to 0.21). Antioxidant vitamins alone showed an observed benefit, but this effect was not statistically significant compared with placebo (χ(2) = 3.76; P = 0.052; absolute risk reduction 0.07, 0.005 to 0.15). L-arginine plus antioxidant vitamins compared with antioxidant vitamins alone resulted in a significant effect (P = 0.004; absolute risk reduction 0.09, 0.05 to 0.14).
  
  
  CONCLUSIONS
  Supplementation during pregnancy with a medical food containing L-arginine and antioxidant vitamins reduced the incidence of pre-eclampsia in a population at high risk of the condition. Antioxidant vitamins alone did not have a protective effect for prevention of pre-eclampsia. Supplementation with L-arginine plus antioxidant vitamins needs to be evaluated in a low risk population to determine the generalisability of the protective effect, and the relative contributions of L-arginine and antioxidant vitamins to the observed effects of the combined treatment need to be determined. Trial registration Clinical trials NCT00469846.
authors: Department of Experimental Medicine, School of Medicine, Universidad Nacional, Autonoma de Mexico, Torre de Investigacion, 3er Piso, Ciudad Universitaria, Mexico, DF 04510. felipe.vadillo@gmail.com
authors: Felipe
authors: F
authors: Vadillo-Ortega
authors: Otilia
authors: O
authors: Perichart-Perera
authors: Salvador
authors: S
authors: Espino
authors: Marco Antonio
authors: MA
authors: Avila-Vergara
authors: Isabel
authors: I
authors: Ibarra
authors: Roberto
authors: R
authors: Ahued
authors: Myrna
authors: M
authors: Godines
authors: Samuel
authors: S
authors: Parry
authors: George
authors: G
authors: Macones
authors: Jerome F
authors: JF
authors: Strauss
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