Acceptability of Nutrient Supplements Among Women and Children in Bangladesh

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129089
• Other study ID #: 200917548-1
• Secondary ID: 4001-UCD-00
• Status: Completed
• Phase: N/A
• First received: May 13, 2010
• Last updated: May 20, 2010
• Start date: December 2009
• Est. completion date: February 2010

Study information

• Verified date: May 2010
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 49 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• Lipid-based nutrient supplement
Lipid-based nutrient supplement for pregnant and lactating women
• Lipid-based nutrient supplement
Lipid-based nutrient supplement for infant and young children
• Micronutrient powder
Micronutrient powder for infant and young children

Locations

Country	Name	City	State
Bangladesh	Fatejangpur	Chirirbandar	Dinajpur

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	United States Agency for International Development (USAID)

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No