Acceptability of Nutrient Supplements Among Women and Children in Bangladesh

University of California (UC) Davis

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: Lipid-based nutrient supplement; Dietary Supplement: Micronutrient powder

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01129089

273918

4001-UCD-00 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: All

Ages: 6 months to 49 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Exclusion criteria for LNS-Child and MNP-Child arm:

• Severely malnourished [mid-upper arm circumference (MUAC) < 115 mm]

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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144 participants in 3 patient groups

LNS-PLW

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Lipid-based nutrient supplement

Dietary Supplement: Lipid-based nutrient supplement

LNS-Child

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Lipid-based nutrient supplement

Dietary Supplement: Lipid-based nutrient supplement

MNP-Child

Experimental group

Description:

There will be 48 infant and young children(IYC) in this arm. They will receive MNP on day 2 and day 3.

Treatment:

Dietary Supplement: Micronutrient powder