Prenatal Iron Supplements: Safety & Efficacy in Tanzania

描述（由申请人提供）：贫血在怀孕期间很常见，并且会增加不良妊娠结局的风险，包括低出生体重。缺铁是撒哈拉以南非洲地区贫血的主要原因，在许多国家，常规补铁已成为孕期护理的标准。然而，最近在儿童中进行的试验结果引起了人们对疟疾流行地区补铁安全性的担忧。在对文献进行全面审查后，关于产前补铁的安全性和有效性的证据有限，特别是在疟疾高负担地区和非贫血妇女中。为了解决这一重要的研究缺口，我们提议在坦桑尼亚的1500名孕妇中进行随机临床试验。参与者将被随机分配每天服用60毫克硫酸亚铁或安慰剂，并将在产后随访。贫血（在坦桑尼亚定义为Hb<8.5）或缺铁（铁蛋白<12 pg/L）的妇女将按照标准护理接受铁治疗，但不参加试验。主要目的是确定坦桑尼亚孕妇补充铁的安全性和有效性，通过与安慰剂相比，胎盘疟疾感染的发生率和密度以及母体血红蛋白浓度和婴儿出生体重来衡量。次要目的是研究与安慰剂相比，铁补充剂对孕产妇贫血、低出生体重和孕产妇疟疾感染发生率的影响。补充剂使用的依从性将通过在每月的诊所访问中直接询问妇女和药片数量来评估。还将对依从性的生化评估进行评估，在随机分组和分娩时测量300名妇女的血清铁蛋白血浆浓度。这项研究将作为波士顿哈佛大学公共卫生学院与坦桑尼亚达累斯萨拉姆Muhimbili卫生与相关科学大学之间合作的一部分进行。

DESCRIPTION (provided by applicant): Anemia is common in pregnancy, and increases the risks of adverse pregnancy outcomes including low birth weight. Iron deficiency is a leading cause of anemia in sub-Saharan Africa, and routine iron supplementation has become the standard of care during pregnancy in many countries. However, findings from recent trials among children have raised concerns regarding the safety of iron supplementation in malaria-endemic regions. After a thorough review of the literature, there is limited evidence on the safety and efficacy of prenatal iron supplementation, especially in areas of high malaria burden and among women who are not anemic. In order to address this important research gap, we propose a randomized clinical trial among 1,500 pregnant women in Tanzania. Participants will be randomized to receive 60 milligrams of ferrous sulphate or placebo daily, and will be followed up through the postpartum period. Women who are anemic (defined in Tanzania as Hb<8.5) or iron deficient (ferritin<12 pg/L) will receive iron, as per standard of care, and will not be enrolled in the trial. The primary aims are to determine the safety and efficacy of iron supplementation among pregnant Tanzanian women, as measured by the incidence and density of placental malaria infection, and maternal hemoglobin concentrations and infant birth weight, compared to placebo. Secondary aims are to examine the efficacy of iron supplements on the incidence of maternal anemia, low birth weight, and maternal malaria infection, compared to placebo. Compliance with supplement use will be assessed by direct questioning of women and pill count at monthly clinic visits. Biochemical assessment of compliance will also be assessed measuring the plasma concentration of serum ferritin in a random subsample of 300 women at randomization and at delivery. The study will be conducted as part of a collaboration between the Harvard School of Public Health in Boston, and Muhimbili University of Health and Allied Sciences in Dar es Salaam, Tanzania. PUBLIC HEALTH RELEVANCE: In sub-Saharan Africa, pregnant women are susceptible to anemia and its adverse effects. Any adverse effects of supplemental iron would be of considerable public health importance in malaria-endemic regions of sub-Saharan Africa, due to the high prevalence of iron deficiency and infectious diseases, and the large number of iron supplements that are routinely distributed.