Individually Randomized Trial of Higher-dose Iron (60 mg, 45 mg) Compared to Low-dose Iron (30 mg) in Multiple Micronutrient Supplements in Pregnancy on Moderate and Severe Maternal Anemia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 6,381
- 试验地点
- 1
- 主要终点
- Proportion of pregnant women with third-trimester moderate or severe anemia
研究概览
简要总结
This is an individually randomized controlled trial to assess the effect of multiple micronutrient supplements (MMS) containing 60 and 45 mg iron as compared to MMS containing 30 mg of iron (standard UNIMMAP formulation) on maternal moderate or severe anemia. This study will help inform countries like Tanzania that currently use IFA containing 60 mg of iron regarding the dose of iron to use in MMS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The trial is quadruple blind with all trial participants, outcome assessors (research staff and care providers), investigators, and trials statistician and data analysts being unable to determine the allocated trial arm for any trial participant or identify trial participants who are on the same trial regimen.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Attending first ANC visit at study clinics
- •Pregnant women < 20 weeks gestation by last menstrual period (LMP)
- •Aged ≥ 18 years old
- •Intending to stay in Dar es Salaam until 6 weeks post delivery
- •Provides informed consent
排除标准
- •Severe anemia (defined as hemoglobin < 8.5 g/dL per Tanzania standard of care)
- •Sickle cell disease (SS and SC) and hemoglobin C disease (CC) as tested by HemoTypeSC
- •Concurrently enrolled in another nutritional clinical trial
- •Pregnant women with disability or condition which would impair their ability to provide informed consent and complete study procedures.
研究组 & 干预措施
MMS with 30 mg iron
MMS with standard UNIMMAP formulation of 15 micronutrients, including 30 mg of iron
干预措施: Multiple Micronutrient Supplements with 30 mg of elemental iron (Dietary Supplement)
MMS with 45 mg iron
MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients
干预措施: Multiple Micronutrient Supplements with 45 mg of elemental iron (Dietary Supplement)
MMS with 60 mg iron
MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients
干预措施: Multiple Micronutrient Supplements with 60 mg of elemental iron (Dietary Supplement)
结局指标
主要结局
Proportion of pregnant women with third-trimester moderate or severe anemia
时间窗: 3rd trimester (weeks 28-42 of pregnancy)
Defined as a hemoglobin concentration \<10 g/dL.
次要结局
- Maternal hemoglobin concentration(6 weeks postpartum)
- Proportion of pregnant women with anemia(3rd trimester (weeks 28-42 of pregnancy))
- Proportion of postpartum women with anemia(6 weeks postpartum)
- Maternal serum ferritin(3rd trimester (weeks 28-42 of pregnancy))
- Proportion of pregnant women with iron deficiency(3rd trimester (weeks 28-42 of pregnancy))
- Proportion of pregnant women with iron deficiency anemia(3rd trimester (weeks 28-42 of pregnancy))
- Proportion of women with preeclampsia(From 20 weeks gestation through delivery)
- Proportion of women with antepartum bleeding(From 24 weeks gestation through delivery)
- Proportion of women with postpartum hemorrhage(From delivery through 42 days post delivery)
- Proportion of women with infection-related severe maternal outcomes(During pregnancy through 42 days postpartum)
- Proportion of women with pregnancy-related death(Pregnancy through 42 days of pregnancy termination)
- Proportion of women with symptoms consistent with depression(6 weeks postpartum)
- Proportion of women with symptoms consistent with fatigue(6 weeks postpartum)
- Proportion of women with malaria infection(Pregnancy through 42 days postpartum)
- Proportion of fetal deaths(At pregnancy termination (weeks 1-42 of pregnancy))
- Proportion of stillbirths(At pregnancy termination (weeks 1-42 of pregnancy))
- Birthweight(At birth)
- Proportion of live births with low birthweight(At birth)
- Gestational age at birth(At birth)
- Proportion of preterm live births(At birth)
- Birthweight for gestational age(At birth)
- Proportion of small-for-gestational age live births (<10th percentile)(At birth)
- Proportion of small-for-gestational age live births (<3rd percentile)(At birth)
- Infant hemoglobin concentration(At 6 weeks of age)
- Infant serum ferritin(At 6 weeks of age)
- Proportion of infants with iron deficiency(At 6 weeks of age)
- Proportion of neonatal deaths(From birth to 28 days of age)
- Proportion of infant deaths < 42 days(From birth to 42 days of age)
研究者
Emily Smith
Principal Investigator
George Washington University