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Acceptability of Nutrient Supplements Among Women and Children in Bangladesh

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ClinicalTrials.gov Identifier: NCT01129089
Recruitment Status : Completed
First Posted : May 24, 2010
Last Update Posted : May 24, 2010
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by:
University of California, Davis

May 13, 2010
May 24, 2010
May 24, 2010
December 2009
January 2010   (Final data collection date for primary outcome measure)
  • 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)
  • 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)
Same as current
No Changes Posted
  • 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.
  • 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.
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Malnutrition
  • Dietary Supplement: Lipid-based nutrient supplement
    Lipid-based nutrient supplement for pregnant and lactating women
    Other Name: LNS
  • Dietary Supplement: Lipid-based nutrient supplement
    Lipid-based nutrient supplement for infant and young children
    Other Name: LNS
  • Dietary Supplement: Micronutrient powder
    Micronutrient powder for infant and young children
    Other Names:
    • MNP
    • Sprinkles
  • 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.
    Intervention: Dietary Supplement: Lipid-based nutrient supplement
  • 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.
    Intervention: Dietary Supplement: Lipid-based nutrient supplement
  • 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.
    Intervention: Dietary Supplement: Micronutrient powder
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
144
Same as current
February 2010
January 2010   (Final data collection date for primary outcome measure)

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]
Sexes Eligible for Study: All
6 Months to 49 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Bangladesh
 
 
NCT01129089
200917548-1
4001-UCD-00 ( Other Grant/Funding Number: Food and Nutrition Technical Assistance II (FANTA-2) )
No
Not Provided
Not Provided
Kathryn G Dewey/Professor, University of California, Davis
University of California, Davis
United States Agency for International Development (USAID)
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
University of California, Davis
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP