Acceptability of Nutrient Supplements Among Women and Children in Bangladesh

This study has been completed.
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01129089
First received: May 13, 2010
Last updated: May 20, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention
Malnutrition
Dietary Supplement: Lipid-based nutrient supplement
Dietary Supplement: Micronutrient powder

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Acceptability of Lipid-based Nutrient Supplements (LNS) and Micronutrient Powder (MNP) for Women and Infants in Bangladesh

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Proportion of test dose consumed [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    Mean consumption of the test dose of LNS for PLW, LNS for IYC and MNP for IYC on day 2 (First test dose)

  • Proportion of test dose consumed [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    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:
  • Proportion of subjects liked the supplements [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained.

  • Proportion of subjects liked the supplement [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained.

  • Proportion of subjects liked the supplement [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
    Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained.

  • Proportion of subjects liked the supplement [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained.


Enrollment: 144
Study Start Date: December 2009
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 infant and young children
Other Name: 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:
  • MNP
  • Sprinkles

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

Ages Eligible for Study:   6 Months to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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]
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129089

Locations
Bangladesh
Fatejangpur
Chirirbandar, Dinajpur, Bangladesh, 5240
Sponsors and Collaborators
University of California, Davis
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
  More Information

No publications provided

Responsible Party: Kathryn G Dewey/Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT01129089     History of Changes
Other Study ID Numbers: 200917548-1, 4001-UCD-00
Study First Received: May 13, 2010
Last Updated: May 20, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Acceptability
Lipid-based nutrient supplements
Micronutrient powder
Malnutrition

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Micronutrients
Trace Elements
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014