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

NCT ID: NCT00885144

Last Updated: 2009-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-06-30

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 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.

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 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.

Conditions

Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 8 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kamuzu University of Health Sciences

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Tampere University

OTHER

Sponsor Role: lead

Responsible Party

University of Tampere

Principal Investigators

Per Ashorn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tampere University

Kenneth Maleta, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

Kamuzu University of Health Sciences

Locations

University of Malawi, College of Medicine

Mangochi, , Malawi

Countries

Malawi

Related Links

http://www.medcol.mw/

College of Medicine homepage

Other Identifiers

iLiNS-ACCEPT-M

Identifier Type: -

Identifier Source: org_study_id