Status:
COMPLETED
Trial on the Acceptability of Modified Lipid Based Nutrient Supplements Among Malawian Infants
Lead Sponsor:
Tampere University
Collaborating Sponsors:
Kamuzu University of Health Sciences
University of California, Davis
Conditions:
Malnutrition
Eligibility:
All Genders
8-12 years
Phase:
PHASE1
Brief Summary
The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. The investig...
Detailed Description
In the first phase, 18 infants meeting set criteria are randomised into receiving three test meals with novel LNS preparations over a three-day period. The meals will consists of the following, each g...
Eligibility Criteria
Inclusion
- Signed informed consent from at least one guardian
- Age 7.50 months to 11.49 months
- Currently breastfeeding
- Consuming complementary feeds at least 30 days prior to enrollment
- Availability during the period of the study
Exclusion
- Weight for length Z score (WFH) ≤ -2.0 using WHO growth reference standards or the -presence of oedema
- Severe systemic illness warranting hospital referral
- History of allergy towards peanut
- History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
- Congenital malformation such as cleft palate which may interfere with food intake
- Concurrent participation in any other clinical trial
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00885144
Start Date
April 1 2009
End Date
June 1 2009
Last Update
June 24 2009
Active Locations (1)
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1
University of Malawi, College of Medicine
Mangochi, Malawi