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Completed

NCT Number: NCT01129089

Acceptability of Nutrient Supplements Among Women and Children in Bangladesh

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.

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Key information

Age range

6 month–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fatejangpur

Chirirbandar, Dinajpur, 5240, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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]

Treatment and study plan

Lipid-Based Nutrient Supplement

Dietary Supplement

Lipid-based nutrient supplement for pregnant and lactating women

Other names: LNS

micronutrient powder

Dietary Supplement

Micronutrient powder for infant and young children

Other names: MNP, Sprinkles

Primary outcomes

  1. Proportion of test dose consumed

    Time frame: 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)

  2. Proportion of test dose consumed

    Time frame: 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 outcomes

  1. Proportion of subjects liked the supplements

    Time frame: Day 2

    Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained.

  2. Proportion of subjects liked the supplement

    Time frame: Day 3

    Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained.

  3. Proportion of subjects liked the supplement

    Time frame: Day 8

    Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained.

  4. Proportion of subjects liked the supplement

    Time frame: Day 15

    Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • United States Agency for International Development (USAID)

Registry information

Official study title

Acceptability of Lipid-based Nutrient Supplements (LNS) and Micronutrient Powder (MNP) for Women and Infants in Bangladesh

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 24, 2010
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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