Acceptability of Nutrient Supplements Among Women and Children in Bangladesh

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

Study Overview

• Status: Completed
• Conditions: Malnutrition
• Intervention / Treatment: Dietary supplement: Lipid-based nutrient supplement; Dietary supplement: Lipid-based nutrient supplement; Dietary supplement: Micronutrient powder

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 Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Dinajpur
    • Chirirbandar, Dinajpur, Bangladesh, 5240
      • Fatejangpur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 49 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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]

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Lipid-based nutrient supplement; Lipid-based nutrient supplement for pregnant and lactating women; Other Names: LNS; Dietary supplement: Lipid-based nutrient supplement; Lipid-based nutrient supplement for infant and young children; Other Names: LNS
Experimental: 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.	Dietary supplement: Lipid-based nutrient supplement; Lipid-based nutrient supplement for pregnant and lactating women; Other Names: LNS; Dietary supplement: Lipid-based nutrient supplement; Lipid-based nutrient supplement for infant and young children; Other Names: LNS
Experimental: MNP-Child; There will be 48 infant and young children(IYC) in this arm. They will receive MNP on day 2 and day 3.	Dietary supplement: Micronutrient powder; Micronutrient powder for infant and young children; Other Names: Sprinkles; MNP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: United States Agency for International Development (USAID)
• Investigators: Principal Investigator: Katnryn G Dewey, Ph.D., University of California, Davis; Study Director: Malay K Mridha, MBBS,MPH, University of Callifornia, Davis; Study Director: Camila M Chaparro, Ph.D., Academy for Educational Development

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: May 13, 2010
• First Submitted That Met QC Criteria: May 20, 2010
• First Posted (Estimated): May 24, 2010

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 20, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Malnutrition; Acceptability; Micronutrient powder; Lipid-based nutrient supplements
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Micronutrients; Trace Elements
• Other Study ID Numbers: 273918; 4001-UCD-00 (Other Grant/Funding Number: Food and Nutrition Technical Assistance II (FANTA-2))