Prevention of Linear Growth Failure in Infants and Young Children With Lipid-based Nutrient Supplements (iLiNS-DOSE)

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. Modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. Such modified products have proven acceptable to infants and their guardians in Malawi and Ghana. In the present trial, the investigator aim to identify the lowest growth-promoting daily dose of modified LNS. Additionally, the investigators will test a hypothesis that LNS that does not contain milk promotes growth as well as milk-containing LNS when given for 12 months at a 10-40 g daily dose to 6-18 month old infants in rural Malawi.

Conditions

• Malnutrition

Interventions

DIETARY_SUPPLEMENT

Lipid-based nutrient supplement, 10gM

* 140 g of milk-containing LNS (LNS-10gM) 2-weekly (10 g / day) between 6 and 18 months of age * Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring

DIETARY_SUPPLEMENT

Lipid-based nutrient supplement, 20gM

* 280 g of milk-containing LNS (LNS-20gM) 2-weekly (20 g / day) between 6 and 18 months of age * Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring

DIETARY_SUPPLEMENT

Lipid-based Nutrient Supplement, 20gNoM

* 280 g of milk-free LNS (LNS-20gNoM) 2-weekly (20 g / day) between 6 and 18 months of age * Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring

DIETARY_SUPPLEMENT

Lipid-based nutrient supplement, 40gM

* 560 g of milk-containing LNS (LNS-40gM) 2-weekly (40 g / day) between 6 and 18 months of age * Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring

DIETARY_SUPPLEMENT

Lipid-based Nutrient Supplement, 40gNoM

* 560 g of milk-free LNS (LNS-40gNoM) 2-weekly (40 g / day) between 6 and 18 months of age * Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring

DIETARY_SUPPLEMENT

Maize-soy flour

* No food supplement during the primary trial period (6 to 18 months of age) * 1 kg fortified maize / soy flour (Likuni phala, LP) 2-weekly (71 g / day) between 18 and 30 months of age * Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring

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 · University of Tampere Medical School

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

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

167 Days

Max Age

197 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-11-30

Primary Completion

2012-08-31

Completion

2014-08-31

Countries

• Malawi

Study Locations