跳至主要内容
临床试验/NCT02747316
NCT02747316已完成不适用

Maternal Iron Absorption and Utilization and Iron Transfer to the Fetus During Pregnancy in Normal Weight and Overweight/Obese Women and the Effects on Infant Iron Status

Swiss Federal Institute of Technology2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
2
主要终点
infants iron status

研究概览

简要总结

Overweight and obesity causes low-grade systemic inflammation, which sharply increases risk for iron deficiency. Studies in our laboratory have shown that this is mainly the result of reduced dietary iron absorption because of increased hepcidin concentrations. During pregnancy, women have a large increase in iron needs because of the expansion of maternal blood volume and fetal needs. Iron deficiency anemia in infancy can impair cognitive development. Whether maternal adiposity impairs absorption and transfer of iron to the fetus, and thereby increases risk of iron deficiency in the mother and the infant is unclear.

详细描述

In obese subjects, hepcidin concentrations are increased and iron absorption is believed to be reduced, leading to iron deficiency over time. How all this will influence iron supply of the fetus in obese pregnancy has not been well investigated to date. Even if maternal and fetal iron uptakes are regulated separately, it is unclear to what extent maternal subclinical inflammation might influence this process. A small study by Dao et al. indicated that maternal-fetal iron transfer was impaired in obese pregnant women, possibly due to hepcidin up-regulation. In this study, both maternal BMI as well as hepcidin were negatively correlated with cord blood iron status. Maternal hepcidin and c-reactive protein were significantly higher and cord blood iron was significantly lower in the obese compared to the normal weight. Hepcidin was shown to have an effect on iron transfer across the placenta in the study by Young et al.: the transfer was increased in women with undetectable hepcidin at delivery compared to those with higher levels. As of now, clear associations between maternal BMI or maternal hepcidin concentration and fetal iron status were not shown.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women with either normal pre-pregnancy BMI (BMI 18.5 - 24.9kg/kg2) or with overweight or obesity (BMI > 27.5kg/m2) before pregnancy (assessed based on data reported by the women at their first visit at the hospital)
  • 18 to 45 years old
  • singleton pregnancy
  • week of pregnancy 14±3

排除标准

  • underlying malabsorption disease
  • chronic illness, which influences iron absorption
  • inflammatory status other than obesity
  • medical problems known to affect iron homeostasis
  • smoking during pregnancy
  • no regular use of medication, which influences iron absorption

结局指标

主要结局

infants iron status

时间窗: over the first six months of life

infants iron status

iron transfer from the mother to the fetus in cord blood/infant

时间窗: delivery

To determine the amount of iron transferred from the mother to the fetus

Fractional iron absorption

时间窗: week 30 of pregnancy

The fractional iron absorption from the second test meal will be calculated based on the shift of the iron isotopic ratios in the collected blood samples 14 days after administration of the isotopically labeled meal.

次要结局

  • Assessment of children's iron needs within their first 2 years of life using an isotope dilution technique(Follow-up blood samples at 3, 6, 12, 18, 24 months after birth)
  • Assessment of recovery of mother's iron Status after pregnancy using an isotope dilution technique(Follow-up blood samples at 3, 6, 12, 18, 24 months after delivery)
  • Change in hemoglobin(weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery)
  • Change in c-reactive protein(weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery)
  • Change in riboflavin(weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery)
  • Change in transferrin receptor(weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery)
  • Change in plasma ferritin(weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery)
  • Change in Hepcidin(weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery)
  • infants iron status(over the first 24 months of life)
  • Change in interleukin-6(weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery)
  • Chage in alpha-1-acid glycoprotein(weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery)
  • Change in retinol binding protein(weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Isabelle Herter-Aeberli

Dr.

Swiss Federal Institute of Technology

研究点 (2)

Loading locations...

相似试验