Fawzi 2010.

Trial name or title	Prenatal iron supplements: safety and efficacy in Tanzania.
Methods	Randomised clinical trial.
Participants	Inclusion criteria: ‐ at or before 19 weeks of gestation ‐ primigravida or secundigravidae ‐ not‐anaemic (defined as Hb < 85 g/L) ‐ not iron deficient (defined as serum ferritin < 12 µg/L) ‐ HIV‐uninfected ‐ intend to stay in Dar es Salaam until delivery and for at least 6 weeks thereafter. Exclusion criteria: ‐ after 19 weeks' gestation ‐ not primigravida or secundigravidae ‐ anaemic ‐ iron deficient ‐ HIV‐infected ‐ high iron stores at baseline (i.e. serum ferritin > 200 µg/L) ‐ do not intend to stay in Dar es Salaam until delivery and for at least 6 weeks thereafter.
Interventions	60 mg elemental iron (as ferrous sulphate) versus placebo.
Outcomes	Primary: incidence of placental malaria (time frame: delivery); infant birthweight (time frame: delivery); maternal Hb (time frame: 20 weeks' gestation); maternal Hb (time frame: 30 weeks' gestation); maternal Hb (time frame: 6 weeks postpartum); maternal Hb (time frame: delivery); placental malaria parasite density (time frame: delivery).  Secondary: low birthweight (time frame: delivery); maternal anaemia (time frame: 20 weeks' gestation); maternal anaemia (time frame: 30 weeks' gestation); maternal anaemia (time frame: 6 weeks postpartum); maternal anaemia (time frame: delivery); maternal malaria infection (time frame: 20 weeks' gestation); maternal malaria infection (time frame: 30 weeks' gestation); maternal malaria infection (time frame: 6 weeks postpartum); maternal malaria infection (time frame: delivery).
Starting date	June 2010.
Contact information	Wafaie W Fawzi, MD, DrPh Telephone:  +1 617 432‐5299 Email:  mina@hsph.harvard.edu Harvard School of Public Health   Zul Premji, MD, MSC, PhD Muhimbili University of Health and Allied Sciences
Notes	Funded by Harvard School of Public Health and Muhimbili University of Health and Allied Sciences.