Individually Randomized Crossover Trial of Multiple Micronutrient Supplementation (MMS) Iron Dosages During Pregnancy in Tanzania
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Acceptability of MMS formulations
研究概览
简要总结
This is an individually randomized cross-over trial to assess acceptability, preference, and perceived side effects of MMS formulations with 30 mg, 45 mg and 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
- 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 the study clinic
- •Pregnant women ≤ 15 weeks of gestation
- •Aged ≥ 18 years
- •Intending to stay in Dar es Salaam 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
MM 60mg; then MMS 30mg; then MMS 45mg
Participants first receive MMS with 60 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 45 mg of iron for one month
干预措施: Multiple Micronutrient Supplements with 30 mg of elemental iron (Dietary Supplement)
MM 30mg; then MMS 45mg; then MMS 60mg
Participants first receive MMS with 30 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 60 mg of iron for one month
干预措施: Multiple Micronutrient Supplements with 30 mg of elemental iron (Dietary Supplement)
MM 30mg; then MMS 45mg; then MMS 60mg
Participants first receive MMS with 30 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 60 mg of iron for one month
干预措施: Multiple Micronutrient Supplements with 45 mg of elemental iron (Dietary Supplement)
MM 30mg; then MMS 60mg; then MMS 45mg
Participants first receive MMS with 30mg for one month, then MMS with 60mg of iron for one month, then MMS with 45 mg of iron for one month
干预措施: Multiple Micronutrient Supplements with 30 mg of elemental iron (Dietary Supplement)
MM 30mg; then MMS 60mg; then MMS 45mg
Participants first receive MMS with 30mg for one month, then MMS with 60mg of iron for one month, then MMS with 45 mg of iron for one month
干预措施: Multiple Micronutrient Supplements with 60 mg of elemental iron (Dietary Supplement)
MM 60mg; then MMS 30mg; then MMS 45mg
Participants first receive MMS with 60 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 45 mg of iron for one month
干预措施: Multiple Micronutrient Supplements with 45 mg of elemental iron (Dietary Supplement)
MM 30mg; then MMS 45mg; then MMS 60mg
Participants first receive MMS with 30 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 60 mg of iron for one month
干预措施: Multiple Micronutrient Supplements with 60 mg of elemental iron (Dietary Supplement)
MM 30mg; then MMS 60mg; then MMS 45mg
Participants first receive MMS with 30mg for one month, then MMS with 60mg of iron for one month, then MMS with 45 mg of iron for one month
干预措施: Multiple Micronutrient Supplements with 45 mg of elemental iron (Dietary Supplement)
MM 45mg; then MMS 30mg; then MMS 60mg
Participants first receive MMS with 45 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 60 mg of iron for one month
干预措施: Multiple Micronutrient Supplements with 30 mg of elemental iron (Dietary Supplement)
MM 45mg; then MMS 30mg; then MMS 60mg
Participants first receive MMS with 45 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 60 mg of iron for one month
干预措施: Multiple Micronutrient Supplements with 45 mg of elemental iron (Dietary Supplement)
MM 45mg; then MMS 30mg; then MMS 60mg
Participants first receive MMS with 45 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 60 mg of iron for one month
干预措施: Multiple Micronutrient Supplements with 60 mg of elemental iron (Dietary Supplement)
MM 45 mg; then MMS 60mg; then MMS 30mg
Participants first receive MMS with 45 mg for one month, then MMS with 60 mg of iron for one month, then MMS with 30 mg of iron for one month
干预措施: Multiple Micronutrient Supplements with 30 mg of elemental iron (Dietary Supplement)
MM 45 mg; then MMS 60mg; then MMS 30mg
Participants first receive MMS with 45 mg for one month, then MMS with 60 mg of iron for one month, then MMS with 30 mg of iron for one month
干预措施: Multiple Micronutrient Supplements with 45 mg of elemental iron (Dietary Supplement)
MM 45 mg; then MMS 60mg; then MMS 30mg
Participants first receive MMS with 45 mg for one month, then MMS with 60 mg of iron for one month, then MMS with 30 mg of iron for one month
干预措施: Multiple Micronutrient Supplements with 60 mg of elemental iron (Dietary Supplement)
MM 60mg; then MMS 30mg; then MMS 45mg
Participants first receive MMS with 60 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 45 mg of iron for one month
干预措施: Multiple Micronutrient Supplements with 60 mg of elemental iron (Dietary Supplement)
MM 60mg; then MMS 45mg; then MMS 30mg
Participants first receive MMS with 60 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 30 mg of iron for one month
干预措施: Multiple Micronutrient Supplements with 30 mg of elemental iron (Dietary Supplement)
MM 60mg; then MMS 45mg; then MMS 30mg
Participants first receive MMS with 60 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 30 mg of iron for one month
干预措施: Multiple Micronutrient Supplements with 45 mg of elemental iron (Dietary Supplement)
MM 60mg; then MMS 45mg; then MMS 30mg
Participants first receive MMS with 60 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 30 mg of iron for one month
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 MMS formulations
时间窗: At one month of taking each regimen
Participant reported acceptability of each MMS formulation using Likert scales ranging from 1 (disliked a lot) to 5 (liked a lot).
Acceptability of MMS formulations
时间窗: At one month of taking each regimen, up to 3 months
Participant reported acceptability of each MMS formulation using Likert scales ranging from 1 (disliked a lot) to 5 (liked a lot).
次要结局
- Most preferred MMS formulation(At three months (after taking all three regimens))
- Most preferred MMS formulation(At three months (after taking all three regimens))
- Least preferred MMS formulation(At three months (after taking all three regimens))
- Identification of MMS iron dosage(At three months (after taking all three regimens))
- Adherence(At one month of taking each regimen)
- Side effects of MMS formulations(At one month of taking each regimen, up to 3 months)
- Adherence(At one month of taking each regimen, up to 3 months)
研究者
Emily Smith
Principal Investigator
George Washington University