Acceptability of Nutrient Supplements Among Women and Children in Bangladesh

Not Applicable

Completed

• Conditions: Malnutrition
• Interventions: Dietary Supplement: Micronutrient powder; Dietary Supplement: Lipid-based nutrient supplement

• Registration Number: NCT01129089
• Lead Sponsor: University of California, Davis

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.

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2010-01
• Study Completion: 2010-02
• Status Verified: 2010-05
• Study First Submitted: 2010-05-13
• Study First Submitted QC: 2010-05-20
• Last Update Submitted: 2010-05-20
• Study First Posted: 2010-05-24
• Last Update Posted: 2010-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MNP-Child	Micronutrient powder	There will be 48 infant and young children(IYC) in this arm. They will receive MNP on day 2 and day 3.
LNS-Child	Lipid-based nutrient supplement	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.
LNS-PLW	Lipid-based nutrient supplement	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.

Primary Outcome Measures

Name	Time	Method
Proportion of test dose consumed	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)

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects liked the supplement	Day 15	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.

Trial Locations

Locations (1)

Fatejangpur; 🇧🇩 Chirirbandar, Dinajpur, Bangladesh