CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 840 target
Drug / intervention
Milk-containing fortified spread +2 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT00524446
NCT00524446Phase 3Completed
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A Single-centre, Randomised, Single-blind, Parallel Group Clinical Trial in Rural Malawi, Testing the Growth Promoting Effect of Long-term Complementary Feeding of Infants With a High-energy, Micronutrient Fortified Spread

Tampere University·interventional·Posted Sep 3, 2007·Updated May 21, 2014

In Brief

A Phase 3 clinical trial evaluating Milk-containing fortified spread, Soy-containing fortified spread, and 1 other intervention for Malnutrition and 2 related conditions. Completed, enrolled 840 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalnutrition, Stunting, Developmental Delay
CountriesMalawi
CollaboratorsKamuzu University of Health Sciences, Academy of Finland, Foundation for Paediatric Research, Finland, Tampere University Hospital

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 3, 2007
Enrollment StartJan 1, 2008
Primary CompletionJun 1, 2011
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 18.8 years ago

Interventions

Milk-containing fortified spreaddietary

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.

Soy-containing fortified spreaddietary

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.

Maize-soy flourdietary

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.