NCT00131222

Brief Summary

This study tests the hypothesis that underweight 6-17-month old infants receiving fortified spread as a food supplement for 12 weeks grow better during the supplementation than infants who are provided with maize-soy flour supplement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2005

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
7 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
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

May 20, 2014

Status Verified

April 1, 2007

First QC Date

August 16, 2005

Last Update Submit

May 19, 2014

Conditions

Malnutrition

Keywords

InfantMalnutritionSub-Saharan AfricaTreatmentGrowthHaemoglobinFortified spreadFood supplement

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • Length gain during the study period (mm)

  • Tibial length gain during the study period (mm)

  • 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])

Interventions

Food supplement: fortified spreadPROCEDURE
Food supplement: maize and soy flourPROCEDURE

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
  • Ages 6.00 months to 14.99 months
  • Weight-for-age \< -2 z-scores
  • Availability during the period of the study
  • Permanent resident of the area

You may not qualify if:

  • WHZ \< -3 z-scores or presence of oedema
  • History of peanut allergy
  • 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

    STUDY DIRECTOR

  • Kenneth M Maleta, MBBS, PhD

    Kamuzu University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 16, 2005

First Posted

August 17, 2005

Study Start

February 1, 2005

Study Completion

September 1, 2005

Last Updated

May 20, 2014

Record last verified: 2007-04

Locations

MA(1)