Malnutrition
Conditions
Keywords
Acceptability, Lipid-based nutrient supplements, Micronutrient powder, Malnutrition
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTLipid-based nutrient supplement
Lipid-based nutrient supplement for pregnant and lactating women
DIETARY_SUPPLEMENTMicronutrient powder
Micronutrient powder for infant and young children
Sponsors
United States Agency for International Development (USAID)
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 49 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of test dose consumed | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects liked the supplement | Day 3 | Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained. |
| Proportion of subjects liked the supplements | Day 2 | Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained. |
Countries
Bangladesh
Outcome results
None listed