Clinical trial NCT01129089: Acceptability of Nutrient Supplements Among Women and Children in Bangladesh
Official title: Acceptability of Lipid-based Nutrient Supplements (LNS) and Micronutrient Powder (MNP) for Women and Infants in Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Acceptability
Lipid-based nutrient supplements
Micronutrient powder
Malnutrition
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2010-05-24
Enrollment: 144
Sex: ALL
Minimum age (years): 6
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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 \[mid-upper arm circumference (MUAC) \< 115 mm\]

Primary outcomes:
measure: Proportion of test dose consumed
timeFrame: Day 2
measure: Proportion of test dose consumed
timeFrame: Day 3
Secondary outcomes:
measure: Proportion of subjects liked the supplements
timeFrame: Day 2
measure: Proportion of subjects liked the supplement
timeFrame: Day 3
measure: Proportion of subjects liked the supplement
timeFrame: Day 8
measure: Proportion of subjects liked the supplement
timeFrame: Day 15
Other outcomes:
Locations:
city: Chirirbandar
country: Bangladesh
facility: Fatejangpur
state: Dinajpur
Study officials:
affiliation: University of California, Davis
name: Katnryn G Dewey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Callifornia, Davis
name: Malay K Mridha, MBBS,MPH
role: STUDY_DIRECTOR
affiliation: Academy for Educational Development
name: Camila M Chaparro, Ph.D.
role: STUDY_DIRECTOR
References: