NCT00131209

Brief Summary

This study tests the hypothesis that infants receiving fortified spread as a complementary food for one year grow better and do not become malnourished as often as infants who are provided with maize-soy flour for complementary porridge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2004

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

July 8, 2008

Status Verified

July 1, 2008

Enrollment Period

1.3 years

First QC Date

August 16, 2005

Last Update Submit

July 3, 2008

Conditions

Malnutrition

Keywords

InfantSub-Saharan AfricaComplementary feedingMalnutritionGrowthFortified spreadHaemoglobin

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

  • Length gain during the study period (cm)

  • Cognitive and motor developmental score at the end of trial

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

  • Change in serum ferritin concentration during the study period (µg/l)

  • Mean change in anthropometric indices (weight-for-age z-score [WAZ], weight-for-height z-score [WHZ] and height-for-age z-score [HAZ])

  • +1 more secondary outcomes

Interventions

fortified spread (RUTF)DIETARY_SUPPLEMENT
maize and soy flourDIETARY_SUPPLEMENT

Eligibility Criteria

Age6 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Signed informed consent from at least one guardian
  • Ages 5.50 months to 6.49 months
  • Availability during the period of the study
  • Permanent resident of the area

You may not qualify if:

  • WHZ \< -2.0 z-scores or presence of oedema
  • History of peanut allergy
  • Severe illness warranting hospital referral
  • Concurrent participation of the child 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 Publications (2)

  • Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Postintervention growth of Malawian children who received 12-mo dietary complementation with a lipid-based nutrient supplement or maize-soy flour. Am J Clin Nutr. 2009 Jan;89(1):382-90. doi: 10.3945/ajcn.2008.26483. Epub 2008 Dec 3.

    PMID: 19056572DERIVED

  • Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Complementary feeding with fortified spread and incidence of severe stunting in 6- to 18-month-old rural Malawians. Arch Pediatr Adolesc Med. 2008 Jul;162(7):619-26. doi: 10.1001/archpedi.162.7.619.

    PMID: 18606932DERIVED

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

    STUDY DIRECTOR

  • Kenneth Maleta, MBBS, PhD

    Kamuzu University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2005

First Posted

August 17, 2005

Study Start

October 1, 2004

Primary Completion

January 1, 2006

Study Completion

January 1, 2008

Last Updated

July 8, 2008

Record last verified: 2008-07

Locations

MA(1)