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Acceptability of LNS for Infants and Young Children in Guatemala

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of California, Davis.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Academy for Educational Development
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01148641
First received: June 18, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

This study aims to assess the acceptability of lipid-based nutrient supplements (LNS) for use as nutritional supplements for infants and young children in Guatemala.

The study will be conducted in three phases. Phase 1 will be a test-feeding to compare the acceptability of two different flavors of LNS (peanut and cinnamon) in infants and young children and their mothers or caregivers in terms of taste, smell and texture, as well as amount of the test-dose consumed. In Phase 2, children in the Phase 1 trial will receive a 2-week supply of one of the LNS products, which they will consume daily in their homes for 14 days under real-life conditions. Direct observation of supplement use and in-depth interviews with mothers, caregivers and health staff providing services in communities will be part of this phase too. In Phase 3, focus group discussions will be held with participants (mothers and caregivers) as well as with health staff providing services in communities to discuss different aspects of infant and child feeding and best ways for the LNS product to be used in the context of Guatemala.

We hypothesize that both flavors of LNS will be accepted by Guatemalan infants and young children children and their mothers or caregivers.


Condition Intervention
Malnutrition
 Dietary Supplement: Lipid-based supplement (LNS)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Acceptability of Lipid-based Nutrient Supplements (LNS) for Infants and Young Children in Guatemala

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Acceptability of LNS [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Outcome will be assessed by amount of LNS consumed in the test trial, time of consumption, amount of LNS sachets consumed in the home-use trial and qualitative assessment of mothers and caregivers opinions.


Estimated Enrollment: 40
Study Start Date: May 2010
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
LNS supplement
Test-trial of two LNS flavors.
 Dietary Supplement: Lipid-based supplement (LNS)
Infants and young children will receive 10 g of LNS for test trial during 3 consecutive days and thereafter, 20 g per day for 14 days.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria Infants and Young Children:

  • Children 6-18 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).
  • Not severely malnourished [mid-upper arm circumference (MUAC) > 115 mm].
  • Maternal/caregiver willingness to feed the infant with LNS over a maximum 3 test days, and over the 2 week home-use period, and report on his/her consumption and reactions and practices for daily use. Willingness to participate in discussion groups.
  • Planning to remain in study area for at least the following three weeks.

Exclusion Criteria Infants and Young Children:

  • Children under 6 months of age.
  • All subjects with known peanut, soy or milk allergies.
  • In poor health or ill at the time of recruitment.
  • Severely malnourished children [mid-upper arm circumference (MUAC) < 115 mm].
  • Not willing to participate in study procedures.
  • Leaving the study area in the following three weeks.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01148641

Contacts
Contact: Kathryn G Dewey, PhD 530-752-0851 kgdewey@ucdavis.edu
Contact: Ana B Perez-Exposito, PhD 530-5747104 abperezexposito@ucdavis.edu

Locations
Guatemala
Fundacion de la Caficultura para el Dessarrollo Rural (FUNCAFE) Recruiting
Mazatenango, Suchitepequez, Guatemala, zona 1
Contact: Ana B Perez-Exposito, PhD     50-5747104     abperezexposito@ucdavis.edu    
Principal Investigator: Ana B Perez-Exposito, PhD            
Sponsors and Collaborators
University of California, Davis
Academy for Educational Development
Investigators
Principal Investigator: Kathryn G Dewey, PhD University of California, Davis
  More Information

No publications provided

Responsible Party: Kathryn Dewey / Chair Program in International Nutrition, University of California, Davis
ClinicalTrials.gov Identifier: NCT01148641     History of Changes
Other Study ID Numbers: 201017829
Study First Received: June 18, 2010
Last Updated: June 18, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Lipid-based supplements
LNS
Acceptability
 Infant nutrition
Guatemala
Malnutrition

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 21, 2013