Trial on the Acceptability of Modified Lipid Based Nutrient Supplements Among Malawian Infants

Malnutrition Clinical Trial

— iLiNS-ACCEPT-M  

Official title:

Differential Acceptability of New Lipid Based Nutrient Supplement (LNS) Formulations for Prevention of Moderate Malnutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885144
• Other study ID #: iLiNS-ACCEPT-M
• Status: Completed
• Phase: Phase 1
• First received: April 20, 2009
• Last updated: June 23, 2009
• Start date: April 2009
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: University of Tampere
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: College of Medicine Research and Ethics Committee
• Study type: Interventional

Clinical Trial 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 investigators' study group has developed modified versions of such supplements that theoretically will supplement infants diets better and with lower cost. As a preparation for larger efficacy trials, the investigators now aim to test the acceptability of these supplements among Malawian infants and their guardians. The trial hypothesis is that the infants will consume on average at least 50% of an offered dose that consists of LNS mixed with maize porridge.

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 given on one day and in a random order: 1) 7.5 g of LNS-10gM mixed in 30 g maize-soy porridge, 2) 15 g of LNS-20gM mixed in 30 g maize-soy porridge, 3) 15 g of LNS-20gNoM mixed in 30 g maize-soy porridge. As a run in procedure, each participant will undergo a test feeding session with one of the the test foods on the day before the actual test-feeding period. As a positive control, each participant will undergo test feeding session with standard Nutributter (NB) on the day after the actual test-feeding period.

In the second phase a set of 48 infants are randomised into 3 groups receiving the following food supplements for a period of 2 weeks: 1) 10 g/day of milk-containing, very concentrated LNS (LNS-10gM), 2) 20 g/day of milk-containing, concentrated LNS (LNS-20gM), 3) 20 g/day of milk-free, concentrated LNS (LNS-20 g NoM)

Outcomes measures in the first phase will be assessed through safety reports and quantities of test food consumed by the child and a hedonic scale of acceptability by the mothers of the children. The second phase will be assessed with qualitative outcomes, from data obtained from focus group discussions with the guardians of the infants consuming the test foods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Months to 12 Months

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• Nutributter
Test dose of "standard" supplementary lipid based nutrient supplement (LNS). 15 grams of Nutributter will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.
• LNS-20gM
Test dose of modified LNS-20gM supplementary lipid based nutrient supplement (LNS). 15 grams of LNS-20gM will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.
• LNS-20gNoM
Test dose of modified LNS-20gNoM (milk free) supplementary lipid based nutrient supplement (LNS). 15 grams of LNS-20gNoM will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.
• LNS-10gM
Test dose of modified LNS-10gM supplementary lipid based nutrient supplement (LNS). 15 grams of LNS-10gM will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.

Locations

Country	Name	City	State
Malawi	University of Malawi, College of Medicine	Mangochi

Sponsors (4)

Lead Sponsor	Collaborator
University of Tampere	Bill and Melinda Gates Foundation, University of California, Davis, University of Malawi College of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean amount (in grammes) of test food consumed		within 15 minutes of test feeding	No
Secondary	Mean time taken to consume the intervention dose		15 minutes after test feeding	No
Secondary	Mean rating by the guardians (on a hedonic, 5 point scale)		15 minutes after test feeding	No
Secondary	Overall guardian feedback after a two week supplementation period (qualitative analysis of focus group discussions)		Once, when the children have completed a two-week supplementary feeding period	No

External Links

•   College of Medicine homepage
•   Home page for University of Tampere Medical School, Department of International Health