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Trial record 1 of 1 for:    00970840
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Acceptability of Lipid-Based Nutrient Supplements (LNS) for Women and Infants

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ClinicalTrials.gov Identifier: NCT00970840
Recruitment Status : Completed
First Posted : September 3, 2009
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:

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 or disease Intervention/treatment Phase
Anemia Malnutrition Dietary Supplement: LNS-20gM or LNS-P&L Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Acceptability of Lipid-based Nutrient Supplements (LNS) for Women and Infants
Study Start Date : June 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Proportion of test-meal consumed [ Time Frame: One day ]

Secondary Outcome Measures :
  1. Degree of liking for appearance, aroma, flavor and consistency of LNS product mixed with koko [ Time Frame: 14 days ]
  2. Amount of LNS consumed during the 14-day study period [ Time Frame: 14 days ]


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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00970840     History of Changes
Other Study ID Numbers: 200917060-1
First Posted: September 3, 2009    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: September 2009

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

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders