Clinical trial NCT00885144: Trial on the Acceptability of Modified Lipid Based Nutrient Supplements Among Malawian Infants
Official title: Differential Acceptability of New Lipid Based Nutrient Supplement (LNS) Formulations for Prevention of Moderate Malnutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malnutrition
Keywords: Stunting
Growth failure
Malnutrition
Lipid based nutrient supplement
LNS
Prevention
Malawi
Sub-Saharan Africa
Dietary supplementation
Lead sponsor: Tampere University
Sponsor class: OTHER
Collaborators: name: Kamuzu University of Health Sciences
name: University of California, Davis
name: Bill and Melinda Gates Foundation
First posted: 2009-04-21
Enrollment: 19
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Mean amount (in grammes) of test food consumed
timeFrame: within 15 minutes of test feeding
Secondary outcomes:
measure: Mean time taken to consume the intervention dose
timeFrame: 15 minutes after test feeding
measure: Mean rating by the guardians (on a hedonic, 5 point scale)
timeFrame: 15 minutes after test feeding
measure: Overall guardian feedback after a two week supplementation period (qualitative analysis of focus group discussions)
timeFrame: Once, when the children have completed a two-week supplementary feeding period
Other outcomes:
Locations:
city: Mangochi
country: Malawi
facility: University of Malawi, College of Medicine
Study officials:
affiliation: Tampere University
name: Per Ashorn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kamuzu University of Health Sciences
name: Kenneth Maleta, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: