Iron BioavailabilityNCT03754543
Baby Iron Bioavailability Study
A study testing Labeled iron salt Fe54, Labeled iron salt Fe57 and Labeled iron salt Fe58 in people with Iron Bioavailability, run by Société des Produits Nestlé (SPN) at 1 site in Malawi.
Trial summary
The overall objective of this trial is to investigate the iron bioavailability from new infant cereals in Malawian infants. Read more about this study
- Who is it for?
- Ages 6 to 14 monthsHealthy volunteers can take part
- Conditions the study is for
- Iron Bioavailability
- What is being tested?
- Labeled iron salt Fe54, Labeled iron salt Fe57 and Labeled iron salt Fe58
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteMalawi
- Study dates
- 31 Jan 2019to 12 Jun 2019
- 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 6 to 14 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infant age 6 - 14 months
- Infant exhibits no clinical signs / symptoms of chronic disease or acute illness
- Capillary haemoglobin concentration > 70g/L
- Z-scores for weight-for-age and weight-for-length > -2
- Infant's parent(s) / legally acceptable representative is of legal age of consent, has anticipated residence in the area for the duration of the study, and is willing and able to fulfil the requirements of the study protocol
- Infant is expected to consume the entire 25 g portion during infant cereal feeding based on the Investigator's judgement established via observations of feeding during the adaptation phase
- Infant received a complete dose of intermittent preventive treatment with dihydroartemisinin piperaquine (IPTi-DP) as well a single dose of antihelminth treatment with Albendazole
Who cannot join
- Parents not willing / not able to comply with the requirements of study protocol
- Infants receiving iron-containing supplements in the 2 months prior to enrollment (other supplements are acceptable)
- Infants with allergies or intolerance to wheat, oat, gluten or other ingredients in the test cereals (e.g., celiac disease)
- Infants participating in any other clinical trial prior to enrollment
- Infants or infant's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iron Bioavailability From Fortified Cereal in Malawian Infants
The overall objective of this trial is to investigate the iron bioavailability from new infant cereals in Malawian infants.
Read the detailed description
In 30 infants aged 6 to 14 months old, the investigator will administer in random order over 2 phases separated by 14 days, 5 infant cereals containing either ferrous fumarate (4 meals) or ferrous bisglycinate (1 meal) intrinsically labeled with stable isotopes. The investigator will collect one blood sample at baseline and another sample at the end of each phase, thus 3 samples total. In these samples, fractional iron absorption and markers of iron and inflammation status will be measured . In addition, infant and child acceptability of one of the infant cereals will be assessed by using a questionnaire.
- Conditions
- Iron Bioavailability
- Being tested
- Labeled iron salt Fe54, Labeled iron salt Fe57, Labeled iron salt Fe58
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labeled iron salt Fe54Other
Ferrous fumarate enriched with Fe 54 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving
Labeled iron salt Fe57Other
Ferrous fumarate enriched with Fe 57 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving
Labeled iron salt Fe58Other
Ferrous bisglycinate enriched with Fe 58 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving
| Study group | Role | What they receive |
|---|---|---|
| Testmeal A | Active comparator | A new, whole-grain infant cereal fortified with ferrous fumarate Receives: Other: Labeled iron salt Fe54 |
| Testmeal B | Active comparator | An alternative new whole-grain infant cereal recipe fortified with ferrous fumarate Receives: Other: Labeled iron salt Fe57 |
| Testmeal C | Placebo comparator | An existing, refined grain infant cereal fortified with ferrous fumarate Receives: Other: Labeled iron salt Fe54 |
| Testmeal D | Active comparator | An existing, whole-grain infant cereal fortified with ferrous fumarate Receives: Other: Labeled iron salt Fe57 |
| Testmeal E | Active comparator | An existing, whole-grain infant cereal fortified with ferrous bisglycinate Receives: Other: Labeled iron salt Fe58 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional iron absorption of 54FeFum (test cereal A), 57FeFum (test cereal B), 54FeFum (test cereal C).
Fractional iron absorption of 54FeFum (test cereal A), 57FeFum (test cereal B), 54FeFum (test cereal C). Based on the shift of Fe isotope ratios in the blood samples and the amount of Fe circulating in the body, the amounts of 54Fe and 57Fe isotopic label present in the blood 14 days after the test meal administrations will be calculated on the principle of isotope dilution and considering that the iron isotopic labels are not mono-isotopic
Measured: up to 6 weeks
Secondary outcomes (4)
Fractional iron absorption of 54FeFum (test cereal C), 57FeFum (test cereal D), 58FeBisGly (test cereal E).
Fractional iron absorption of 54FeFum (test cereal C), 57FeFum (test cereal D), 58FeBisGly (test cereal E). Based on the shift of Fe isotope ratios in the blood samples and the amount of Fe circulating in the body, the amounts of 54Fe, 57Fe and 58Fe isotopic label present in the blood 14 days after the test meal administrations will be calculated as described above for the primary endpoint
Measured: up to 6 weeks
Cereal acceptability questionnaire
Measured: up to 2 weeks
Fractional iron absorption from infants with (CRP ≥ 10 mg/L) or without (CRP < 10 mg/L) asymptomatic infection / inflammation.
Measured: up to 6 weeks
Standard reporting of adverse events (AEs) for safety assessment
Reported AEs will include type, incidence, severity, seriousness and relation to intervention. All concomitant medications used to treat illnesses and other conditions will be recorded (both dose and duration).
Measured: time of consent to 24 hours after final blood draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start31 Jan 2019
- Primary completion12 Jun 2019
- Study completion12 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron BioavailabilityStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Swiss Federal Institute of Technology, Kamuzu University of Health Sciences
- Responsible party
- Sponsor
- Investigators
- Kamija Phiri, Prof., Principal investigator, Kamuzu University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754543
- Sponsor's protocol ID
- 18.05.INF
- Status last verified
- Jul 2019
- First submitted
- 4 Oct 2018
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Bioavailability From Fortified Cereal in Malawian Infants
- ClinicalTrials.gov ID
- NCT03754543
- Acronym / sponsor ID
- 18.05.INF
- Conditions
- Iron Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Swiss Federal Institute of Technology, Kamuzu University of Health Sciences
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 27 Nov 2018 (actual)
- 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 overall objective of this trial is to investigate the iron bioavailability from new infant cereals in Malawian infants.
Detailed description
In 30 infants aged 6 to 14 months old, the investigator will administer in random order over 2 phases separated by 14 days, 5 infant cereals containing either ferrous fumarate (4 meals) or ferrous bisglycinate (1 meal) intrinsically labeled with stable isotopes. The investigator will collect one blood sample at baseline and another sample at the end of each phase, thus 3 samples total. In these samples, fractional iron absorption and markers of iron and inflammation status will be measured . In addition, infant and child acceptability of one of the infant cereals will be assessed by using a questionnaire.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Testmeal A | Active comparator | Other: Labeled iron salt Fe54A new, whole-grain infant cereal fortified with ferrous fumarate |
| Testmeal B | Active comparator | Other: Labeled iron salt Fe57An alternative new whole-grain infant cereal recipe fortified with ferrous fumarate |
| Testmeal C | Placebo comparator | Other: Labeled iron salt Fe54An existing, refined grain infant cereal fortified with ferrous fumarate |
| Testmeal D | Active comparator | Other: Labeled iron salt Fe57An existing, whole-grain infant cereal fortified with ferrous fumarate |
| Testmeal E | Active comparator | Other: Labeled iron salt Fe58An existing, whole-grain infant cereal fortified with ferrous bisglycinate |
Who may qualify
- Ages
- 6 to 14 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Infant age 6 - 14 months
- Infant exhibits no clinical signs / symptoms of chronic disease or acute illness
- Capillary haemoglobin concentration > 70g/L
- Z-scores for weight-for-age and weight-for-length > -2
- Infant's parent(s) / legally acceptable representative is of legal age of consent, has anticipated residence in the area for the duration of the study, and is willing and able to fulfil the requirements of the study protocol
Key exclusion criteria (5 listed)
- Parents not willing / not able to comply with the requirements of study protocol
- Infants receiving iron-containing supplements in the 2 months prior to enrollment (other supplements are acceptable)
- Infants with allergies or intolerance to wheat, oat, gluten or other ingredients in the test cereals (e.g., celiac disease)
- Infants participating in any other clinical trial prior to enrollment
- Infants or infant's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures.
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 |
|---|---|---|
| Labeled iron salt Fe54Ferrous fumarate enriched with Fe 54 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving | Other | Testmeal A, Testmeal C |
| Labeled iron salt Fe57Ferrous fumarate enriched with Fe 57 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving | Other | Testmeal B, Testmeal D |
| Labeled iron salt Fe58Ferrous bisglycinate enriched with Fe 58 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving | Other | Testmeal E |
Primary outcome
Fractional iron absorption of 54FeFum (test cereal A), 57FeFum (test cereal B), 54FeFum (test cereal C).
Time frame: up to 6 weeks
Fractional iron absorption of 54FeFum (test cereal A), 57FeFum (test cereal B), 54FeFum (test cereal C). Based on the shift of Fe isotope ratios in the blood samples and the amount of Fe circulating in the body, the amounts of 54Fe and 57Fe isotopic label present in the blood 14 days after the test meal administrations will be calculated on the principle of isotope dilution and considering that the iron isotopic labels are not mono-isotopic
4 secondary outcomes
Fractional iron absorption of 54FeFum (test cereal C), 57FeFum (test cereal D), 58FeBisGly (test cereal E).
Time frame: up to 6 weeks
Cereal acceptability questionnaire
Time frame: up to 2 weeks
Fractional iron absorption from infants with (CRP ≥ 10 mg/L) or without (CRP < 10 mg/L) asymptomatic infection / inflammation.
Time frame: up to 6 weeks
Standard reporting of adverse events (AEs) for safety assessment
Time frame: time of consent to 24 hours after final blood draw
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 16 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Kamija Phiri, Prof. principal investigator
Kamuzu University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Labeled iron salt Fe54, Labeled iron salt Fe57 and Labeled iron salt Fe58 in people with Iron Bioavailability, run by Société des Produits Nestlé (SPN) at 1 site in Malawi.
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 7 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 16 Jul 2019. 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 Malawi. 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. Some participants in this study may receive a placebo. 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?
Fractional iron absorption of 54FeFum (test cereal A), 57FeFum (test cereal B), 54FeFum (test cereal C). (time frame: up to 6 weeks). 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 16 Jul 2019.