TY - JOUR
T1 - Effects of weekly iron and folic acid supplements on malaria risk in nulliparous women in Burkina Faso: a periconceptional, double-blind, randomized controlled noninferiority trial
AU - Gies, Sabine
AU - Diallo, Salou
AU - Roberts, Stephen A.
AU - Kazienga, Adama
AU - Powney, Matthew
AU - Brabin, Loretta
AU - Ouedraogo, Sayouba
AU - Swinkels, Dorine W.
AU - Geurts-Moespot, Anneke J.
AU - Claeys, Yves
AU - D'Alessandro, Umberto
AU - Tinto, Halidou
AU - Faragher, Brian
AU - Brabin, Bernard
N1 - PPU; CUNIT
PY - 2018
Y1 - 2018
N2 - Background. The safety of iron supplementation for young women is uncertain in malaria-endemic settings.Methods. This was a double-blind, randomized controlled noninferiority trial in rural Burkina Faso.Results. A total of 1959 nulliparae were assigned to weekly supplementation (60 mg iron and 2.8 mg folic acid) (n = 980) or 2.8 mg folic acid (n = 979) until first antenatal visit (ANC1), or 18 months if remaining nonpregnant. Three hundred fifteen women attended ANC1, and 916 remained nonpregnant. There was no difference at ANC1 in parasitemia prevalence (iron, 53.4% [95% confidence interval {CI}, 45.7%-61.0%]; control, 55.3% [95% CI, 47.3%-62.9%]; prevalence ratio, 0.97 [95% CI,.79-1.18]; P=.82), anemia (adjusted effect, 0.96 [95% CI,.83-1.10]; P=.52), iron deficiency (adjusted risk ratio [aRR], 0.84 [95% CI,.46-1.54]; P=.58), or plasma iron biomarkers. Outcomes in nonpregnant women were parasitemia (iron, 42.9% [95% CI, 38.3%-47.5%]; control, 39.2% [95% CI, 34.9%-43.7%]; prevalence ratio, 1.09 [95% CI,.93-1.28]; P=.282); anemia (aRR, 0.90 [95% CI,.78-1.05]; P=.17), and iron deficiency (aRR, 0.99 [95% CI,.77-1.28]; P=.96), with no iron biomarker differences.Conclusions. Weekly iron supplementation did not increase malaria risk, improve iron status, or reduce anemia in young, mostly adolescent menstruating women, nor in early pregnancy. World Health Organization Guidelines for universal supplementation for young nulliparous women may need reassessment.
AB - Background. The safety of iron supplementation for young women is uncertain in malaria-endemic settings.Methods. This was a double-blind, randomized controlled noninferiority trial in rural Burkina Faso.Results. A total of 1959 nulliparae were assigned to weekly supplementation (60 mg iron and 2.8 mg folic acid) (n = 980) or 2.8 mg folic acid (n = 979) until first antenatal visit (ANC1), or 18 months if remaining nonpregnant. Three hundred fifteen women attended ANC1, and 916 remained nonpregnant. There was no difference at ANC1 in parasitemia prevalence (iron, 53.4% [95% confidence interval {CI}, 45.7%-61.0%]; control, 55.3% [95% CI, 47.3%-62.9%]; prevalence ratio, 0.97 [95% CI,.79-1.18]; P=.82), anemia (adjusted effect, 0.96 [95% CI,.83-1.10]; P=.52), iron deficiency (adjusted risk ratio [aRR], 0.84 [95% CI,.46-1.54]; P=.58), or plasma iron biomarkers. Outcomes in nonpregnant women were parasitemia (iron, 42.9% [95% CI, 38.3%-47.5%]; control, 39.2% [95% CI, 34.9%-43.7%]; prevalence ratio, 1.09 [95% CI,.93-1.28]; P=.282); anemia (aRR, 0.90 [95% CI,.78-1.05]; P=.17), and iron deficiency (aRR, 0.99 [95% CI,.77-1.28]; P=.96), with no iron biomarker differences.Conclusions. Weekly iron supplementation did not increase malaria risk, improve iron status, or reduce anemia in young, mostly adolescent menstruating women, nor in early pregnancy. World Health Organization Guidelines for universal supplementation for young nulliparous women may need reassessment.
KW - iron
KW - malaria
KW - adolescents
KW - nonpregnant
KW - pregnant
KW - CLINICAL-TRIAL
KW - PARASITEMIA
KW - INFECTION
KW - HEPCIDIN
KW - ANEMIA
U2 - 10.1093/infdis/jiy257
DO - 10.1093/infdis/jiy257
M3 - A1: Web of Science-article
VL - 218
SP - 1099
EP - 1109
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
SN - 0022-1899
IS - 7
ER -