Oral Iron Supplementation on Alternate vs. Consecutive Days for Iron Deficiency Anemia in Pregnancy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- reversal of iron deficient anemia
研究概览
简要总结
This will be a randomized clinical trial. Enrolled subjects will be randomized (1:1) into two study arms to receive either daily (Group 1) or alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill.
详细描述
During the enrollment (baseline) visit, subjects will undergo a blood draw to assess hemoglobin, ferritin and soluble transferrin receptor (sTfR) levels to confirm current depleted iron stores and will then be randomly allocated into one of the two study arms. All ferrous sulfate (oral tablets) will be provided to patients by the investigators. All subjects will be instructed to take oral iron on an empty stomach or 1 hour after meals for better absorption, preferably with a vitamin C rich product such as orange juice. To minimize variability introduced by other potential iron sources, prenatal vitamins that have the same amount and form of iron will be provided to both study groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Pregnant patients will be enrolled at less than 30 weeks gestational age (GA) with laboratory confirmed IDA (as defined by hemoglobin under 10.5 g/dL, as well as ferritin under 15 mcg/L)
排除标准
- •Patients <18 years old, patients who have severe IDA that requires blood transfusion or IV iron infusion, patients who have other known hemoglobinopathy (such as thalassemia or sickle cell anemia) or anemia of different mechanism (such as vitamin B12 or folate deficiency), patients with ulcerative colitis, Crohn's disease, gastric ulcers, patients who have previously undergone gastric bypass surgery, patients who experience admission for antepartum bleed, have been diagnosed with abnormal placentation (i.e., placenta previa, placenta accreta, placenta increta or percreta)
研究组 & 干预措施
1) Daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill
daily (Group 1) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill
干预措施: daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill (Drug)
2) Alternate daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill
alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill
干预措施: alternate day ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill (Drug)
结局指标
主要结局
reversal of iron deficient anemia
时间窗: 8 weeks after the baseline visit ± 7 days
hemoglobin \> 10.5 g/dL
次要结局
- soluble transferrin receptor (sTfR) levels within normal range(8 weeks after the baseline visit ± 7 days)