Acceptability of Lipid-Based Nutrient Supplements (LNS) for Women and Infants
Acceptability of Lipid-based Nutrient Supplements (LNS) for Women and Infants
1 other identifier
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 1, 2009
CompletedFirst Posted
Study publicly available on registry
September 3, 2009
CompletedMarch 27, 2017
September 1, 2009
Same day
September 1, 2009
March 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of test-meal consumed
One day
Secondary Outcomes (2)
Degree of liking for appearance, aroma, flavor and consistency of LNS product mixed with koko
14 days
Amount of LNS consumed during the 14-day study period
14 days
Study Arms (1)
LNS-20gM or LNS-P&L
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- months of age
- currently receiving breast milk
- has been consuming complementary foods for at least 30 days
- being ≥ 18 years of age
- confirmed to be pregnant or breastfeeding
You may not qualify if:
- intolerance to milk or peanut
- illness requiring referral
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Martins de Porres Hospital
Agomanya, Ghana
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kathryn G. Dewey, PhD
UC Davis
- PRINCIPAL INVESTIGATOR
Anna Lartey, PhD
University of Ghana
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2009
First Posted
September 3, 2009
Study Start
June 1, 2009
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
March 27, 2017
Record last verified: 2009-09