Assessment of Iron Absorption and Requirements During Pregnancy and Lactation in Kenyan Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Iron absorbed, lossed and gained in infancy
研究概览
简要总结
Iron requirements increase significantly during pregnancy. Current recommendations for iron intake in pregnant and lactating women (PLW) are mainly based on factorial estimates and extrapolated from non-PLW. High-quality quantitative data on iron requirements in PLW are lacking, particularly in Sub- Saharan Africa where anaemia and infections are common.
The primary objective of this study is to use the stable iron isotope technique to determine iron requirements and assess iron absorption and losses in PLW living in Kenya.
In this prospective observational study, we will enrol pregnant women in the first trimester (n = 250) from a previous study cohort (n=1000) who participated in an iron absorption study at least 12 months ago and received the stable iron (Fe) isotope 57Fe. This 57Fe has now distributed and equilibrated throughout the women's body iron. Once enrolled in the present study, following Kenyan guidelines, women will receive standard prenatal care, including routine daily iron and folate supplementation. We will collect venous blood samples in each trimester and at delivery, and during the first 6 months of lactation in the mothers and infants (heel prick samples). To directly assess dietary iron absorption, in a randomly selected subset of women (n=35), oral and intravenous stable iron isotope tracers (54Fe, 58Fe) will be administered in the 2nd and 3rd trimesters.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Providing consent to the informed consent form
- •Participation in a previous stable isotope absorption study and having received an oral dose of 15 mg 57Fe at least 12 months prior to the date of inclusion in the study
- •Positive pregnancy test and gestational age <10 weeks based on history of last menstrual period
- •Permanent residence in the study area, and not expected to leave the study site for more than 4 weeks over the following 16 months
- •Assessment of good health by professional staff at Msambweni Hospital
排除标准
- •Pre-pregnancy body mass index >30 kg/m2
- •Blood transfusion or intravenous iron treatment within 4 months of study start
- •Major chronic infectious disease (e.g., tuberculosis, HIV+, hepatitis)
- •Major chronic non-infectious disease (e.g., Type 1 or 2 diabetes, cancer)
结局指标
主要结局
Iron absorbed, lossed and gained in infancy
时间窗: Change in 57Fe tracer abundance between age 6, 14 and 24 weeks
isotope dilution
Iron absorbed, lossed and gained in the first trimester
时间窗: Change in 57Fe tracer abundance between gestational age 6, 10 and 15 weeks
isotope dilution
Iron absorbed, lossed and gained in the second trimester
时间窗: Change in 57Fe tracer abundance between gestational age 15, 20 and 25 weeks
isotope dilution
Iron absorbed, lossed and gained in the third trimester
时间窗: Change in 57Fe tracer abundance between gestational age 25, 30 and 35 weeks
isotope dilution
Iron absorbed, lossed and gained throughout pregnancy
时间窗: Change in 57Fe tracer abundance between gestational age 6, 10, 15, 20, 25, 30 and 35 weeks
isotope dilution
Iron absorbed, lossed and gained in lactating women
时间窗: Change in 57Fe tracer abundance between 6, 14 and 24 weeks postpartum
isotope dilution
次要结局
- Blood volume (l)(24 weeks postpartum)
- Erythrocyte iron incorporation (%) in the second trimester(gestational age 20 weeks)
- Fractional iron absorption (%) in the second trimester(gestational age 20 weeks)
- Fractional iron absorption (%) in the third trimester(gestational age 30 weeks)
- Erythroferrone concentration (ng/ml)(24 weeks postpartum)
- C-reactive protein concentration (mg/l)(age 24 weeks)
- alpha-glycoprotein concentration (mg/dl)(age 24 weeks)
- Erythrocyte iron incorporation (%) in the third trimester(gestational age 30 weeks)
- Hemoglobin concentration (g/dl)(age 24 weeks)
- Mean corpuscular volume (fl)(age 24 weeks)
- Erythropoietin concentration (mU/ml)(24 weeks postpartum)
- Intestinal fatty acid binding protein(gestational age 30 weeks)
- Hepcidin concentration (ng/ml)(24 weeks postpartum)
- Serum ferritin concentration (ug/l)(age 24 weeks)
- Soluble transferrin receptor concentration (ul/l)(age 24 weeks)
- Retinol binding protein(gestational age 30 weeks)
- Insulin-like growth factor 1(gestational age 30 weeks)
- soluble CD14(gestational age 30 weeks)
- Fibroblast growth factor 21(gestational age 30 weeks)