Individually Randomized Crossover Trial of Multiple Micronutrient Supplementation (MMS) Versus IFA During Pregnancy in Tanzania
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 130
- 主要终点
- Acceptability of formulation
研究概览
简要总结
This is an open-label individually randomized mixed methods cross-over trial to assess acceptability, preference, and side effects of IFA formulations with 60 mg of iron to MMS formulations with 60 mg of iron.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
None (Open label)
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 the study clinic
- •Pregnant women ≤ 15 weeks of gestation
- •Aged ≥ 18 years
- •Intending to stay in the study area for the duration of study
- •Provides informed consent
排除标准
- •Severe anemia (defined as Hb <8.5 g/dL per Tanzania standard of care)
- •Sickle cell disease (SS,SC, CC genotype) as tested by HemoTypeSC
- •Concurrent participation in other nutritional supplementation 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 60 mg of iron first, then IFA with 60 mg of iron
Women will receive the first regimen (MMS with 60 mg of iron) for 2 months and then crossover on to the second regimen (IFA with 60 mg of iron) for 2 months
干预措施: Iron Folic Acid Tablets with 60 mg of iron (Dietary Supplement)
MMS with 60 mg of iron first, then IFA with 60 mg of iron
Women will receive the first regimen (MMS with 60 mg of iron) for 2 months and then crossover on to the second regimen (IFA with 60 mg of iron) for 2 months
干预措施: Multiple Micronutrient Supplements with 60 mg of elemental iron (Dietary Supplement)
IFA with 60 mg of iron first, then MMS with 60 mg of iron
Women will receive the first regimen (IFA with 60 mg of iron) for 2 months and then crossover on to the second regimen (MMS with 60 mg of iron) for 2 months
干预措施: Iron Folic Acid Tablets with 60 mg of iron (Dietary Supplement)
IFA with 60 mg of iron first, then MMS with 60 mg of iron
Women will receive the first regimen (IFA with 60 mg of iron) for 2 months and then crossover on to the second regimen (MMS with 60 mg of iron) for 2 months
干预措施: Multiple Micronutrient Supplements with 60 mg of elemental iron (Dietary Supplement)
结局指标
主要结局
Acceptability of formulation
时间窗: At two months of taking each regimen
To assess acceptability of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron using Likert scales ranging from 1 (disliked a lot) to 5 (liked a lot).
次要结局
- Adherence(At two months of taking each regimen)
- Most preferred formulation(At four months (after taking both regimens))
- Side Effects of formulation(At two months of taking each regimen)
研究者
Emily Smith
Principal Investigator
George Washington University