NCT00386074

Brief Summary

The purpose of this study is to assess whether NaFeEDTA and electrolytic iron improve iron status of young school children, when added as iron fortificants in whole maize flour.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
412

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2004

Shorter than P25 for phase_2

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

May 1, 2004

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
Last Updated

April 21, 2010

Status Verified

April 1, 2010

First QC Date

October 10, 2006

Last Update Submit

April 20, 2010

Conditions

Anaemia

Keywords

NaFeEDTAelectrolytic ironefficacywhole maize flourphytateschool-age childrencontrolled trialAfrica

Outcome Measures

Primary Outcomes (3)

  • Haemoglobin

  • Plasma Ferritin

  • Plasma Transferrin receptor

Secondary Outcomes (3)

  • Iron deficiency anaemia

  • Iron deficiency

  • Anaemia

Interventions

NaFeEDTA, Electrolytic IronDRUG

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years age (for the purposes of this study this will include children born within the period December 15th 1995- May 1st 2001).
  • Whohave been resident in the area for 6 months or more.
  • Enrolled in the selected schools
  • Able to consume the target amount of porridge, at least 50% of the time during the run-in period
  • Will be present in the study area for the entire study period (April - December 2004).

You may not qualify if:

  • Children below 3 years and above 8 years of age (born after December 15th 1995 and before May 1st 2001).
  • Children who have been resident in the area for less than 6 months at the time of recruitment.
  • Children with obvious physical and mental disability.
  • Severely malnourished children.
  • Severely anaemic children (Hb \<70g/L).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Andang'o PE, Osendarp SJ, Ayah R, West CE, Mwaniki DL, De Wolf CA, Kraaijenhagen R, Kok FJ, Verhoef H. Efficacy of iron-fortified whole maize flour on iron status of schoolchildren in Kenya: a randomised controlled trial. Lancet. 2007 May 26;369(9575):1799-1806. doi: 10.1016/S0140-6736(07)60817-4.

    PMID: 17531887DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Fe(III)-EDTA

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Pauline EA Andang'o, MND

    Wageningen University

    PRINCIPAL INVESTIGATOR

  • David L Mwaniki, PhD

    Kenya Medical Research Institute

    PRINCIPAL INVESTIGATOR

  • Hans Verhoef, PhD

    Wageningen University

    PRINCIPAL INVESTIGATOR

  • Saskia JM Osendarp, PhD

    Unilever Food and Health Institute, Vlaardingen, The Netherlands

    STUDY DIRECTOR

  • Frans J Kok, PhD

    Wageningen University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2006

First Posted

October 11, 2006

Study Start

May 1, 2004

Study Completion

December 1, 2004

Last Updated

April 21, 2010

Record last verified: 2010-04