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.
Study Goal
The researchers aimed to determine whether weekly iron supplementation is safe and effective in reducing malaria risk, improving iron status, or reducing anemia in young, mostly adolescent menstruating women in malaria-endemic settings.
Results Summary
The study found no significant differences in parasitemia prevalence, anemia, or iron deficiency between the iron supplementation and control groups, indicating that weekly iron supplementation did not increase malaria risk, improve iron status, or reduce anemia in the studied population.
Population
Young, mostly adolescent, nulliparous women in rural Burkina Faso.
Effective Dosage
60 mg iron and 2.8 mg folic acid weekly.
Duration
Until first antenatal visit or 18 months if remaining nonpregnant.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
weekly supplementation (60 mg iron and 2.8 mg folic acid) | no change | parasitemia prevalence | women at first antenatal visit (ANC1) | prevalence ratio, 0.97 [95% CI, .79-1.18]; P = .82 | There was no difference | #1 |
weekly supplementation (60 mg iron and 2.8 mg folic acid) | no change | anemia | women at first antenatal visit (ANC1) | adjusted effect, 0.96 [95% CI, .83-1.10]; P = .52 | There was no difference | #2 |
weekly supplementation (60 mg iron and 2.8 mg folic acid) | no change | iron deficiency | women at first antenatal visit (ANC1) | adjusted risk ratio [aRR], 0.84 [95% CI, .46-1.54]; P = .58 | There was no difference | #3 |
weekly supplementation (60 mg iron and 2.8 mg folic acid) | no change | plasma iron biomarkers | women at first antenatal visit (ANC1) | - | There was no difference | #4 |
weekly supplementation (60 mg iron and 2.8 mg folic acid) | no change | parasitemia | nonpregnant women | prevalence ratio, 1.09 [95% CI, .93-1.28]; P = .282 | Outcomes | #5 |
weekly supplementation (60 mg iron and 2.8 mg folic acid) | no change | anemia | nonpregnant women | aRR, 0.90 [95% CI, .78-1.05]; P = .17 | Outcomes | #6 |
weekly supplementation (60 mg iron and 2.8 mg folic acid) | no change | iron deficiency | nonpregnant women | aRR, 0.99 [95% CI, .77-1.28]; P = .96 | Outcomes | #7 |
weekly supplementation (60 mg iron and 2.8 mg folic acid) | no change | iron biomarkers | nonpregnant women | no differences | Outcomes | #8 |
Weekly iron supplementation | no change | malaria risk | young, mostly adolescent menstruating women | - | did not increase | #9 |
Weekly iron supplementation | no change | iron status | young, mostly adolescent menstruating women | - | did not improve | #10 |
Weekly iron supplementation | no change | anemia | young, mostly adolescent menstruating women | - | did not reduce | #11 |
Weekly iron supplementation | no change | malaria risk | women in early pregnancy | - | did not increase | #12 |
Weekly iron supplementation | no change | iron status | women in early pregnancy | - | did not improve | #13 |
Weekly iron supplementation | no change | anemia | women in early pregnancy | - | did not reduce | #14 |
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. CLINICAL TRIALS REGISTRATION: NCT01210040.