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Iron DeficiencyNCT01321099

Iron Absorption From Complementary Food Fortificants (CFFs) and Acceptability of CFFs by Beninese Children

A study testing NaFeEDTA, Phytase and Vitamin C in people with Iron Deficiency and Anemia, run by Swiss Federal Institute of Technology at 1 site in Benin.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Iron deficiency (ID) is still a main public health problem in sub-Saharan Africa. Iron deficient children have an increased risk for anemia which is associated with adverse infant development that might be partly irreversible. Read more about this study

Who is it for?
Ages 12 to 36 monthsHealthy volunteers can take part
Conditions the study is for
Iron Deficiency, Anemia
What is being tested?
NaFeEDTA, Phytase and Vitamin C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBenin
Study dates
May 2011to Sep 2012
Phase
Interventional
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 12 to 36 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Female or male children, 12 - 36 months of age
  • A body weight of at least 8.3 kg; weight for age ≥ -3 Z-score
  • No malaria parasites in the blood smear + negative malaria rapid test
  • No hematuria
  • No intake of mineral/vitamin supplements 2 weeks before and during the study
  • No metabolic or gastrointestinal disorders

Who cannot join

  • Fever (body temperature > 37.5 °C)
  • Severe anemia (hemoglobin < 8.0 g/dl)
  • Regular intake of medication
  • Blood transfusion or significant blood loss (accident, surgery) over the past 4 months
  • Currently participating in another clinical trial or having participated in another clinical trial during the last 3 months prior to the beginning of this study
  • Former participation in a study involving administration of iron stable isotopes
  • Subject who cannot be expected to comply with study protocol
  • Eating disorders or food allergy

Trial locations and contacts

1 site in 1 country.

Benin1 site
  • University of Abomey-Calavi

    Cotonou, Cotonou, 562

Other trials in Benin

About this study

Iron deficiency (ID) is still a main public health problem in sub-Saharan Africa. Iron deficient children have an increased risk for anemia which is associated with adverse infant development that might be partly irreversible. In sub-Saharan Africa, the etiology of ID in children is multifactoral; but the major causes are low iron dietary bioavailability and intake from monotonous cereal-based complementary foods. Children < 5 years old can benefit from iron-fortified complementary foods; however, these fortified complementary foods are often not adapted to the requirements of children in specific setting. The investigators developed a complementary food fortificant (CFF) which is added to local porridge and is deemed to meet the nutrient intake requirement for iron in children 1-3 years of age. The CFF is lipid-based and can therefore, if regularly used, increase the daily energy intake of children which is often too low in developing countries with cereal-based diets.

The iron absorption from the mixture of CFF and porridge has to be optimized because it contains quite a high amount of phytate, a well-known inhibitor of iron absorption. To optimize iron absorption the investigators are planning three iron absorption studies using different compounds of iron (FeSO4 + NaFeEDTA), additional vitamin C and phytase, which is able to degrade phytate. In the first study, iron absorption will be determined from a mixture of CFF and porridge fortified with 1) 6 mg FeSO4 and 2) 6 mg FeSO4 plus additional vitamin C. In the second study, the test meals will be fortified with 1) 6 mg FeSO4 and 2) a mixture of 3 mg FeSO4 + 3 mg NaFeEDTA. In the third study, test meals will be fortified with 1) 6 mg FeSO4, 2) 6 mg FeSO4 plus phytase, and 3) 6 mg FeSO4 plus additional vitamin C and phytase. Iron absorption will be determined by incorporation of labeled iron into erythrocytes, 14 days after the administration of a test meal containing labeled iron (stable isotope technique). Sixty apparently healthy Beninese children 12-36 months of age with a body weight > 8.3 kg will be included in the study. Additionally, the investigators will test acceptability of CFFs based on different composition formulas by interviewing the parents/legal guardians of the children after feeding the CFF for a defined period.

The results of these studies will provide important insights to optimize the iron absorption of young children from a CFF mixed with local traditional porridge in developing countries. Furthermore the studies will provide information on the acceptability of CFFs in such a setting.

Being tested
NaFeEDTA, Phytase, Vitamin C
Keywords
Iron absorption, Complementary food fortificant, Young children
Medical subject headings
Iron Deficiencies, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NaFeEDTAOther

    Labeled iron as FeSO4 or NaFeEDTA added to a test meal

  • PhytaseOther

    Labeled iron as FeSO4 added to a test meal with or without phytase and with or without vitamin C

  • Vitamin COther

    Labeled iron as FeSO4 added to a test meal with or without vitamin C

Study groups in NCT01321099
Study groupRoleWhat they receive
NaFeEDTAExperimentalNot described
Receives: Other: NaFeEDTA
PhataseExperimentalNot described
Receives: Other: Phytase
Vitamin CExperimentalNot described
Receives: Other: Vitamin C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Iron isotope ratio in blood samples

    Whole blood samples will be collected to measure the shift in iron isotope ratios 16 days after administration of isotopic label in the first test meal.

    First test meal on study day 1, Second test meal on study day 2, Third (last) test meal on study day 3, Measurement of iron isotopic shift in blood samples collected on study day 17

    Measured: Study day 17 (16 days after administration of isotopic label in the first test meal/End of the study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionJun 2012
  4. Study completionSep 2012

Resources

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 N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01321099
Sponsor's protocol ID
CFF_Fe_Study
Status last verified
Nov 2012
First submitted
22 Mar 2011
Last updated
8 Nov 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing NaFeEDTA, Phytase and Vitamin C in people with Iron Deficiency and Anemia, run by Swiss Federal Institute of Technology at 1 site in Benin.

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 6 inclusion and 8 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 8 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Benin. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

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?

Iron isotope ratio in blood samples (time frame: Study day 17 (16 days after administration of isotopic label in the first test meal/End of the study)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 8 Nov 2012.

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