Acceptability of Lipid-based Nutrient Supplements (LNS) and Micronutrient Powder (MNP) for Women and Infants in Bangladesh
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Proportion of test dose consumed
研究概览
简要总结
The study aims to confirm the acceptability of lipid-based nutrient supplements (LNS) for use as nutritional supplements for pregnant and lactating women (PLW) or infants and young children (IYC) and micronutrient powder (MNP) for use as nutritional supplements for infants and young children in Bangladesh.We hypothesized that at least 75 percent of the test dose of LNS and MNP offered to PLW and IYC will be consumed by them.
详细描述
The study will be conducted in three steps. Step 1 will be a test-feeding to compare the acceptability of each "version" of the LNS-child (LNS-child with cardamom flavor, LNS-child with no added flavor),LNS-PLW (LNS-PLW with cumin flavor, and LNS-PLW with no added flavor) and MNP to the others in terms of taste, smell and texture, as well as amount of the test-dose consumed. In Step 2, participants in the Phase 1 trial will receive a 2-week supply of one of the LNS products or MNP, which they will consume daily in their homes for 14 days under real-life conditions. In Step 3, focus group discussions will be held with participants to discuss different aspects of infant and child feeding and discuss best ways for the LNS or MNP product to be used in the context of Bangladesh.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for LNS-PLW arm:
- •Pregnant women in their second or third trimester (in case of third trimester pregnancy, the expected date of delivery is not within three weeks) or lactating women with a child between 3 days and 6 months of age
- •At least 18 years of age
- •No life-threatening pregnancy-related complications (e.g., pre-eclampsia, antepartum hemorrhage)
- •Apparently healthy and not presently suffering from an acute illness (e.g., fever, diarrhea, acute respiratory tract infection)
- •Living in the study area for at least 6 months
- •Planning to remain in study area for at least the following three weeks.
排除标准
- •for LNS-PLW arm:
- •Known allergy to peanuts or other food products (as reported on the screening questionnaire)
- •Inclusion criteria for LNS-Child and MNP-Child arm:
- •Children 6-24 months of age
- •Consuming solid foods for at least the past 30 days
- •Apparently healthy and not presently suffering from an acute illness (e.g., fever, diarrhea, acute respiratory tract infection)
- •No known allergy to peanuts or other food products (as reported on the screening questionnaire by the mother/primary caregiver)[LNS-Child only]
- •Planning to remain in study area for at least the following three weeks.
- •Exclusion criteria for LNS-Child and MNP-Child arm:
- •Severely malnourished [mid-upper arm circumference (MUAC) < 115 mm]
研究组 & 干预措施
LNS-PLW
There will be 48 pregnant or lactating women (PLW) in this arm. They will be randomized to receive cumin flavored LNS-PLW or LNS-PLW with no added flavor on day 2. On day 3, the PLW getting a test-dose of cumin flavored LNS-PLW on day 2 will receive LNS-PLW with no added flavor and the PLW getting a test-dose of LNS-PLW with no added flavor on day 2 will receive cumin flavored LNS-PLW.
干预措施: Lipid-based nutrient supplement (Dietary Supplement)
LNS-Child
There will be 48 infant and young children(IYC) in this arm. They will be randomized to receive cardamom flavored LNS-Child or LNS-Child with no added flavor on day 2. On day 3, the IYC getting a test-dose of LNS-Child with no added flavor on day 2 will receive cardamom flavored LNS-Child and the IYC getting a test-dose of cardamom flavored LNS-Child on day 2 will receive LNS-Child with no added flavor.
干预措施: Lipid-based nutrient supplement (Dietary Supplement)
MNP-Child
There will be 48 infant and young children(IYC) in this arm. They will receive MNP on day 2 and day 3.
干预措施: Micronutrient powder (Dietary Supplement)
结局指标
主要结局
Proportion of test dose consumed
时间窗: Day 3
Mean consumption of the test dose of LNS for PLW, LNS for IYC and MNP for IYC on day 3(Second test dose)
Proportion of test dose consumed
时间窗: Day 2
Mean consumption of the test dose of LNS for PLW, LNS for IYC and MNP for IYC on day 2 (First test dose)
次要结局
- Proportion of subjects liked the supplement(Day 15)
- Proportion of subjects liked the supplements(Day 2)
- Proportion of subjects liked the supplement(Day 3)
- Proportion of subjects liked the supplement(Day 8)