AnaemiaPhase 2NCT00386074
Iron-fortified Whole Maize Flour Trial
A Phase 2 study testing NaFeEDTA, Electrolytic Iron in people with Anaemia, run by Wageningen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Anaemia
- What is being tested?
- NaFeEDTA, Electrolytic Iron
- How many people
- 412 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Dec 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 3-8 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).
Who cannot join
- 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).
About this study
Official title: The Efficacy of Iron Fortified Whole Maize Flour on the Iron Status of School Children in Kenya
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.
Read the detailed description
Fortification of staple foods with iron may be an effective method of addressing the problem of iron deficiency. Questions however remain of the type of iron fortificants to use, the appropriate fortification levels and suitable food vehicles. Cereals form attractive vehicles because they are widely consumed in parts of the world that bear a large burden of the iron deficiency problem. They are however high in phytates and would reduce the bioavailability of commonly used iron fortificants. Isotope studies have shown that even in the presence of phytates, iron from NaFeEDTA is relatively more bioavailable than that from other fortificant sources. Its efficacy has however not been assessed in human trials. Electrolytic iron, on the other hand is widely used and was legislated as the iron fortificant of choice in South Africa. Its efficacy in a high-phytate vehicle has also not been assessed. We have therefore undertaken to assess the efficacy of NaFeEDTA at two doses, as an iron fortificant in whole flour, and the efficacy of electrolytic iron at a dose similar to the high-dose NaFeEDTA. The results will contribute information on the suitability of these fortificants in whole maize flour, a food commonly consumed in sub-Saharan Africa.
- Conditions
- Anaemia
- Being tested
- NaFeEDTA, Electrolytic Iron
- Keywords
- NaFeEDTA, electrolytic iron, efficacy, whole maize flour, phytate, school-age children, controlled trial, Africa
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaFeEDTA, Electrolytic IronDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin
Plasma Ferritin
Plasma Transferrin receptor
Secondary outcomes (3)
Iron deficiency anaemia
Iron deficiency
Anaemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startMay 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 412 participants
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever Food and Health Research Institute, The Netherlands, Kenya Medical Research Institute, Akzo Nobel
- Investigators
- Pauline EA Andang'o, MND, Principal investigator, Wageningen UniversityDavid L Mwaniki, PhD, Principal investigator, Kenya Medical Research InstituteHans Verhoef, PhD, Principal investigator, Wageningen UniversitySaskia JM Osendarp, PhD, Study director, Unilever Food and Health Institute, Vlaardingen, The NetherlandsFrans J Kok, PhD, Study chair, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386074
- Sponsor's protocol ID
- 6107050200
- Status last verified
- Apr 2010
- First submitted
- 10 Oct 2006
- Last updated
- 21 Apr 2010
- Results posted
- No
Publications
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.
PubMed 17531887
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Iron Fortified Whole Maize Flour on the Iron Status of School Children in Kenya
- ClinicalTrials.gov ID
- NCT00386074
- Acronym / sponsor ID
- 6107050200
- Conditions
- Anaemia
- Keywords
- NaFeEDTA, electrolytic iron, efficacy, whole maize flour, phytate, school-age children, controlled trial, Africa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 412 participants
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Unilever Food and Health Research Institute, The Netherlands, Kenya Medical Research Institute, Akzo Nobel
- Study start
- May 2004
- Study completion
- Dec 2004
- First posted
- 11 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fortification of staple foods with iron may be an effective method of addressing the problem of iron deficiency. Questions however remain of the type of iron fortificants to use, the appropriate fortification levels and suitable food vehicles. Cereals form attractive vehicles because they are widely consumed in parts of the world that bear a large burden of the iron deficiency problem. They are however high in phytates and would reduce the bioavailability of commonly used iron fortificants. Isotope studies have shown that even in the presence of phytates, iron from NaFeEDTA is relatively more bioavailable than that from other fortificant sources. Its efficacy has however not been assessed in human trials. Electrolytic iron, on the other hand is widely used and was legislated as the iron fortificant of choice in South Africa. Its efficacy in a high-phytate vehicle has also not been assessed. We have therefore undertaken to assess the efficacy of NaFeEDTA at two doses, as an iron fortificant in whole flour, and the efficacy of electrolytic iron at a dose similar to the high-dose NaFeEDTA. The results will contribute information on the suitability of these fortificants in whole maize flour, a food commonly consumed in sub-Saharan Africa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 3-8 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).
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaFeEDTA, Electrolytic Iron | Drug | – |
Primary outcome
Haemoglobin
Plasma Ferritin
Plasma Transferrin receptor
3 secondary outcomes
Iron deficiency anaemia
Iron deficiency
Anaemia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2010.
- Derived from this study: PubMed 17531887Andang'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauline EA Andang'o, MND principal investigator
Wageningen University
David L Mwaniki, PhD principal investigator
Kenya Medical Research Institute
Hans Verhoef, PhD principal investigator
Wageningen University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NaFeEDTA, Electrolytic Iron in people with Anaemia, run by Wageningen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemoglobin. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00386074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2010.