Acceptability of Nutrient Supplements Among Women and Children in Bangladesh

NCT ID: NCT01129089

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-02-28

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.

Conditions

Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lipid-based nutrient supplement

Intervention Type: DIETARY_SUPPLEMENT

Lipid-based nutrient supplement for pregnant and lactating women

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.

Group Type: EXPERIMENTAL

Lipid-based nutrient supplement

Intervention Type: DIETARY_SUPPLEMENT

Lipid-based nutrient supplement for infant and young children

MNP-Child

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

Group Type: EXPERIMENTAL

Micronutrient powder

Intervention Type: DIETARY_SUPPLEMENT

Micronutrient powder for infant and young children

Interventions

Lipid-based nutrient supplement

Lipid-based nutrient supplement for pregnant and lactating women

Intervention Type: DIETARY_SUPPLEMENT

Lipid-based nutrient supplement

Lipid-based nutrient supplement for infant and young children

Intervention Type: DIETARY_SUPPLEMENT

Micronutrient powder

Micronutrient powder for infant and young children

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

LNS; LNS; MNP; Sprinkles

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• Known allergy to peanuts or other food products (as reported on the screening questionnaire)

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Agency for International Development (USAID)

FED

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katnryn G Dewey, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Malay K Mridha, MBBS,MPH

Role: STUDY_DIRECTOR

University of Callifornia, Davis

Camila M Chaparro, Ph.D.

Role: STUDY_DIRECTOR

Academy for Educational Development

Locations

Fatejangpur

Chirirbandar, Dinajpur, Bangladesh

Countries

Bangladesh

Other Identifiers

4001-UCD-00

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

273918

Identifier Type: -

Identifier Source: org_study_id