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

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.

Conditions

• Malnutrition

Interventions

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.

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.

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.

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.

Sponsors & Collaborators

• Kamuzu University of Health Sciences

  collaborator OTHER

• University of California, Davis

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Tampere University

  lead OTHER

Principal Investigators

• Per Ashorn, MD, PhD · Tampere University

• Kenneth Maleta, MBBS, PhD · Kamuzu University of Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

8 Months

Max Age

12 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-04-30

Primary Completion

2009-06-30

Completion

2009-06-30

Countries

• Malawi

Study Locations