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Acceptability of Lipid-Based Nutrient Supplements (LNS) for Women and Infants

This study has been completed.
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00970840
First received: September 1, 2009
Last updated: September 2, 2009
Last verified: September 2009
History of Changes
  Purpose

Inadequate micronutrient intakes during pregnancy, lactation and infancy remain a major problem in Ghana. Lipid-based nutrient supplements (LNS) made using vegetable oil, groundnut paste, milk, sugar, and micronutrients may offer a solution.

The proposed study will test the acceptability of a lipid-based nutrient supplement designed for infants (LNS-20gM) and another designed for pregnant and lactating women (LNS-P&L). Participants will consume a test meal consisting of LNS-20gM (20 infants) or LNS-P&L (20 pregnant and lactating women) mixed with fermented maize porridge, after which they will be given the respective LNS supplement for use at home for 14 d. Primary outcome is the proportion of the test-meal consumed. The investigators hypothesize that subjects will consume at 75% of the test meal offered.


Condition Intervention
Anemia
Malnutrition
 Dietary Supplement: LNS-20gM or LNS-P&L

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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Proportion of test-meal consumed [ Time Frame: One day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Degree of liking for appearance, aroma, flavor and consistency of LNS product mixed with koko [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Amount of LNS consumed during the 14-day study period [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: June 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LNS-20gM or LNS-P&L Dietary Supplement: LNS-20gM or LNS-P&L
Participants consumed a test meal (45 g or 50 g) consisting of LNS-20gM or LNS-P&L mixed with fermented maize porridge, after which they were provided with the respective LNS supplements for use at home daily for 14 d

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (infants):

  • 6-12 months of age
  • currently receiving breast milk
  • has been consuming complementary foods for at least 30 days

Inclusion Criteria (women):

  • being ≥ 18 years of age
  • confirmed to be pregnant or breastfeeding

Exclusion Criteria:

  • intolerance to milk or peanut
  • illness requiring referral
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970840

Locations
Ghana
St. Martins de Porres Hospital
Agomanya, Ghana
Sponsors and Collaborators
University of California, Davis
Investigators
Study Director: Kathryn G. Dewey, PhD UC Davis
Principal Investigator: Anna Lartey, PhD University of Ghana, Legon
  More Information

No publications provided

Responsible Party: Kathryn G. Dewey, UC Davis
ClinicalTrials.gov Identifier: NCT00970840     History of Changes
Other Study ID Numbers: 200917060-1
Study First Received: September 1, 2009
Last Updated: September 2, 2009
Health Authority: Ghana: Ministry of Health

Keywords provided by University of California, Davis:
Acceptability
Supplements
Home-fortification

Additional relevant MeSH terms:
Anemia
Malnutrition
Hematologic Diseases
Nutrition Disorders

ClinicalTrials.gov processed this record on May 19, 2013