Efficacy and Adverse Side Effects of Two Forms of Iron in Prenatal Micronutrient Supplements (EASE-Iron): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 4
- 主要终点
- Maternal ferritin concentration
研究概览
简要总结
This two-arm, double-blind randomized clinical trial will recruit 172 generally healthy, low-risk pregnant individuals aged 19-42 years living in Vancouver, Canada. Participants will be randomized to receive one of two forms of iron (ferrous fumarate or ferrous bisglycinate) in addition to a prenatal multivitamin (without iron) daily during their pregnancy until delivery, with optional continuation until ~4 weeks postpartum for breastmilk sample collection. Blood samples will be taken at baseline (13-25 weeks gestation) and follow-up (35-37 weeks gestation) to assess how different forms of iron impact body iron stores. Stool samples will be obtained within 1 week of both baseline and follow-up visits to assess changes in gut microbiome composition. This research will inform more specific guidelines for optimal iron supplementation practices for the prevention and treatment of iron deficiency for both mother and baby.
详细描述
To address our primary aim of determining the optimal form of iron in prenatal supplements, we seek to answer the following research questions:
- Does providing a more bioavailable form of iron (24 mg elemental iron as ferrous bisglycinate) effectively increase ferritin concentration in maternal venous blood and umbilical cord blood, as compared to the standard 24 mg elemental iron as ferrous fumarate?
- Does 12 weeks of 24 mg daily oral iron as ferrous fumarate increase biomarkers of potential harm (adverse side effects, gut microbiome composition, gut inflammation) in pregnant individuals, as compared to 24 mg daily oral iron as ferrous bisglycinate?
Pregnant individuals 13-25 weeks gestation will be randomized to one of two trial arms to receive either 24 mg elemental iron as ferrous fumarate or 24 mg elemental iron as ferrous bisglycinate for a minimum of 12 weeks during pregnancy until delivery, with optional continuation until 4-weeks postpartum for breastmilk collection. All participants will also receive the standard form and dose of other critical micronutrients during pregnancy (e.g., folic acid, calcium) through the provision of a prenatal multivitamin (not containing iron).
Interested individuals may undergo the informed consent process anytime prior to 25 weeks gestation. Once an individual indicates that they are interested in participating in the trial, the individual will be assigned a unique study ID and a baseline visit will be scheduled.
The baseline visit will occur between 13-25 weeks gestation and will involve discontinuation of current iron/prenatal vitamin supplementation, review and signing the informed consent form (a scanned copy will be shared with the participant), randomization to an iron group, provision of study supplements, completion of a baseline questionnaire, measurement of weight and height, a small blood draw, and provision of a stool collection kit for at-home stool collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant individual (singleton pregnancy)
- •19-42 years of age
- •Living in the greater Vancouver area and willing to travel to the University of British Columbia or BC Women's Hospital for study visits
- •13-25 weeks gestation
- •Willing to participate and able to provide informed consent
排除标准
- •Having a pre-existing medical condition known to impact iron status (e.g., inherited hemoglobin disorder (i.e., sickle cell, hemochromatosis, thalassemia or other structural hemoglobin variant), malabsorptive disorders (i.e., chronic pancreatitis, cystic fibrosis, celiac disease) and inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), gastric bypass surgery, atrophic gastritis, advanced liver disease, kidney dialysis)
- •Using medications known to interfere with iron metabolism or the gut pathogen equilibrium (e.g., chronic use of proton pump inhibitors, anti-inflammatory agents, non-steroidal anti-inflammatory drugs, antibiotics)
- •Having a personal neural tube defect (NTD) history or a previous NTD pregnancy
- •Receiving ongoing blood transfusions
- •Currently smoking or having smoked in the past 3 months
- •Pre-pregnancy body mass index (BMI) ≥30 kg/m^2
- •Allergy to any study supplement ingredients
研究组 & 干预措施
Ferrous fumarate
24 mg elemental iron/day
干预措施: Ferrous fumarate (Dietary Supplement)
Ferrous bisglycinate
24 mg elemental iron/day
干预措施: Ferrous bisglycinate (Dietary Supplement)
结局指标
主要结局
Maternal ferritin concentration
时间窗: Blood sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation)
µg/L; reflects body iron stores
次要结局
- Maternal hemoglobin concentration(Maternal blood sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation))
- Umbilical cord ferritin concentration(Umbilical cord blood collected at time of delivery)
- Umbilical cord hemoglobin concentration(Umbilical cord blood collected at time of delivery)
- Placental iron concentration(Placenta collected at time of delivery)
- Gut microbial analysis(Stool sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation))
- Adverse side effects(Follow-up (35-37 weeks gestation))
- Markers of inflammation(Maternal blood sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation); umbilical cord blood sample collected at time of delivery)
- Hepcidin concentration(Maternal blood sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation); umbilical cord blood sample collected at time of delivery)
- Breastmilk iron stores(Breastmilk sample collected at 4-weeks postpartum)
研究者
Crystal Karakochuk
Assistant Professor
University of British Columbia