NCT00420758

Brief Summary

This study tests the hypothesis that moderately underweight but not severely wasted 6-17-month old infants receiving fortified spread or maize-spy flour as a food supplement for 12 weeks grow better during the supplementation than infants who do not get any food supplement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
299

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
10 months until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

December 4, 2015

Status Verified

December 1, 2015

Enrollment Period

6 months

First QC Date

January 10, 2007

Last Update Submit

December 3, 2015

Conditions

Malnutrition

Keywords

InfantMalnutritionSub-Saharan AfricaTreatmentGrowthHaemoglobinFortified spreadFood supplement

Outcome Measures

Primary Outcomes (1)

  • Weight gain during the 12-week follow-up (in grams)

    12 weeks

Secondary Outcomes (5)

  • Length gain during the 12-week follow-up (in centimetres

    12 weeks

  • Change in blood haemoglobin concentration during the study period (g/l)

    12 weeks

  • Change in anthropometric indices (WAZ, WHZ and HAZ)

    12 weeks

  • Proportion developing moderate or severe wasting during the intervention (WHM<80% of the reference mean)

    12 weeks

  • Change in mid-upper arm and head circumference

    12 weeks

Study Arms (3)

Control

NO INTERVENTION

LNS

EXPERIMENTAL

Lipid-based nutrient supplement

Dietary Supplement: Food supplement: fortified spread

CSB

EXPERIMENTAL

Corn-soy blend supplement

Dietary Supplement: Food supplement: maize-soy flour

Interventions

Food supplement: fortified spreadDIETARY_SUPPLEMENT

Provision of fortified spread

LNS
Food supplement: maize-soy flourDIETARY_SUPPLEMENT

Provision of corn-soy blend (maize-soy flour)

CSB

Eligibility Criteria

Age6 Months - 15 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • signed informed consent from at least one guardian
  • age 6.00 months to 14.99 months
  • weight-for-age \<-2.0 Z scores
  • availability during the period of the study
  • permanent resident Lungwena Health Centre catchment area

You may not qualify if:

  • moderate or severe wasting (WHM\<80% of the reference median)
  • history of peanut allergy
  • history of any serious allergic reaction to any substance, requiring emergency medical care
  • history of anaphylaxis
  • severe illness warranting hospital referral
  • concurrent participation in another clinical trial with intervention to the child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Medicine, University of Malawi

Mangochi, Mangochi District, Malawi

Location

Related Links

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Per Ashorn, MD, PhD

    University of Tampere, Medical School, Finland

    STUDY DIRECTOR

  • Kenneth Maleta, MBBS, PhD

    University of Malawi, College of Medicine, Department of Community Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR OF PEDIATRICS

Study Record Dates

First Submitted

January 10, 2007

First Posted

January 11, 2007

Study Start

November 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

December 4, 2015

Record last verified: 2015-12

Locations

MA(1)