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Controlled Trial to Test the Efficacy of Lipid-based Nutrient Supplements to Prevent Severe Stunting Among Infants

NCT00524446 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 840

Last updated 2014-05-21

No results posted yet for this study

Summary

This study tests the hypothesis that infants receiving milk-powder containing fortified spread (lipid-based nutrient supplement) as a complementary food for one year have lower incidence of severe stunting (poor length gain) than infants who are provided with no extra food supplements or maize-soy flour for complementary porridge.

Conditions

  • Malnutrition
  • Stunting
  • Developmental Delay

Interventions

DIETARY_SUPPLEMENT

Milk-containing fortified spread

Counseling + Vitamin A as for ST-DI + 750 g of fortified spread (FSm) 2-weekly (54 g / day) between 6 and 18 months of age.

DIETARY_SUPPLEMENT

Soy-containing fortified spread

Counseling + Vitamin A as for ST-DI + 750 g of modified fortified spread (FSs) 2-weekly (54 g / day) between 6 and 18 months of age.

DIETARY_SUPPLEMENT

Maize-soy flour

Counseling + Vitamin A as for ST\_DI + 1 kg fortified maize / soy flour 2-weekly (71 g / day) between 6 and 18 months of age.

Sponsors & Collaborators

  • Kamuzu University of Health Sciences

    collaborator OTHER

  • Academy of Finland

    collaborator OTHER

  • Foundation for Paediatric Research, Finland

    collaborator OTHER

  • Medical Research Fund of the Tampere University Hospital, Finland

    collaborator OTHER

  • Tampere University

    lead OTHER

Principal Investigators

  • Per Ashorn, MD, PhD · University of Tampere Medical School, Finland

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-06-30
Completion
2014-01-31

Countries

  • Malawi

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00524446 on ClinicalTrials.gov