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| ID | Type | Description | Link |
|---|---|---|---|
| 4001-UCD-00 | Other Grant/Funding Number | Food and Nutrition Technical Assistance II (FANTA-2) |
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| Name | Class |
|---|---|
| United States Agency for International Development (USAID) | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LNS-PLW | Experimental | 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. |
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| LNS-Child | Experimental | 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. |
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| MNP-Child | Experimental | There will be 48 infant and young children(IYC) in this arm. They will receive MNP on day 2 and day 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipid-based nutrient supplement | Dietary Supplement | Lipid-based nutrient supplement for pregnant and lactating women |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of test dose consumed | Mean consumption of the test dose of LNS for PLW, LNS for IYC and MNP for IYC on day 2 (First test dose) | Day 2 |
| Proportion of test dose consumed | Mean consumption of the test dose of LNS for PLW, LNS for IYC and MNP for IYC on day 3(Second test dose) | Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects liked the supplements | Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained. | Day 2 |
| Proportion of subjects liked the supplement |
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Inclusion criteria for LNS-PLW arm:
Exclusion criteria for LNS-PLW arm:
Inclusion criteria for LNS-Child and MNP-Child arm:
Exclusion criteria for LNS-Child and MNP-Child arm:
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| Name | Affiliation | Role |
|---|---|---|
| Katnryn G Dewey, Ph.D. | University of California, Davis | Principal Investigator |
| Malay K Mridha, MBBS,MPH | University of Callifornia, Davis | Study Director |
| Camila M Chaparro, Ph.D. | Academy for Educational Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fatejangpur | Chirirbandar | Dinajpur | 5240 | Bangladesh |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Lipid-based nutrient supplement | Dietary Supplement | Lipid-based nutrient supplement for infant and young children |
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| Micronutrient powder | Dietary Supplement | Micronutrient powder for infant and young children |
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Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained.
| Day 3 |
| Proportion of subjects liked the supplement | Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained. | Day 8 |
| Proportion of subjects liked the supplement | Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained. | Day 15 |