Effects of Weekly Iron and Folic Acid Supplements on Malaria Risk in Nulliparous Women in Burkina Faso: A Periconceptional Double-blind Randomized Controlled Non-inferiority Trial

Background:

Safety of iron supplementation for young women is uncertain in malaria endemic settings.

Methods:

Double-blind randomized controlled non-inferiority trial in rural Burkina Faso.

Results:

1959 nulliparae 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 non-pregnant. 315 women attended ANC1, and 916 remained non-pregnant. There was no difference at ANC1 in parasitemia prevalence (iron 53.4%, 95% CI 45.7:61.0; control 55.3%, 95% CI 47.3:62.9; prevalence ratio 0.97, 95% CI 0.79:1.18; P=0.82); anemia (adjusted effect 0.96, 95% CI 0.83:1.10; P=0.52); iron deficiency (adjusted risk ratio 0.84, 95% CI 0.46:1.54; P= 0.58); or plasma iron biomarkers. Outcomes in non-pregnant 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 0.93:1.28; P=0.282); anemia (adjusted risk ratio 0.90, 95% CI 0.78:1.05; P= 0.17); iron deficiency (adjusted risk ratio 0.99, 95% CI 0.77:1.28; 0.96); 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. WHO Guidelines for universal supplementation for young nulliparous women may need re-assessment.

Trial Registration:

ClinicalTrials.gov, number NCT01210040.