Iron AbsorptionNCT01493297
Effects of Vitamin A and Carotenoids on Iron Absorption
A study testing Labeled iron solutions in people with Iron Absorption, run by Swiss Federal Institute of Technology at 1 site in Venezuela.
Trial summary
The objective of this study is to investigate the effect of vitamin A and carotenoids on iron absorption in healthy subjects with low and normal vitamin A status. Vitamin A and carotenoids have been reported to enhance the nonheme iron absorption, but the results from human isotope studies are equivocal. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Absorption
- What is being tested?
- Labeled iron solutions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteVenezuela
- Study dates
- Sep 2011to Jul 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 18 to 52 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women 18-52 years old
- Body weight ≤ 70 kg
- Body mass index (BMI), 18.5-30 kg/m2
- Adequate vitamin A status (SR ≥ 0.7 μmol/L, n=20)
- Inadequate vitamin A status (SR < 0.7 μmol/L, n=20)
- No major medical illnesses (no known infection, gastrointestinal or metabolic disorders)
Who cannot join
- Pregnancy or lactation
- Regular intake of medication (except oral contraceptives)
- Blood donation 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
Trial locations and contacts
1 site in 1 country.
Venezuela1 site
Venezuelan Institute for Scientific Research (IVIC)
Caracas, 1020-A
About this study
The objective of this study is to investigate the effect of vitamin A and carotenoids on iron absorption in healthy subjects with low and normal vitamin A status. Vitamin A and carotenoids have been reported to enhance the nonheme iron absorption, but the results from human isotope studies are equivocal. Radio-iron studies in Venezuelan adults have consistently reported an increase in iron absorption, whereas stable and radio isotopes studies conducted in Sweden and Switzerland reported no influence. Differences in vitamin A status of the subjects may be a possible explanation for the contradictory findings. In this study, iron absorption will be measured from an iron-fortified maize bread meal with or without retinyl palmitate or β-carotene by using both stable- and radioactive-isotope techniques in Venezuelan women with a range of vitamin A status.
- Conditions
- Iron Absorption
- Being tested
- Labeled iron solutions
- Keywords
- Retinyl palmitate, beta-carotene, stable isotopes, radio isotopes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labeled iron solutionsOther
Labeled iron as FeSO4 (4 mg/test meal)
| Study group | Role | What they receive |
|---|---|---|
| Retinyl palmitate | Other | Labeled iron as FeSO4 (4 mg) added to a test meal with or without retinyl palmitate (1000 RE) Receives: Other: Labeled iron solutions |
| Beta-carotene | Other | Labeled iron as FeSO4 (4 mg) added to a test meal with or without beta-carotene (1000 RE) Receives: Other: Labeled iron solutions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional iron absorption
Iron absorption will be estimated by measuring the erythrocyte incorporation of stable (57Fe/58Fe) and radio (55Fe/59Fe) iron isotopes labels given in test meals.
Measured: 1 month after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Iron AbsorptionStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Venezolano de Investigaciones Cientificas
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
- Investigators
- Maria Andersson, Dr, Principal investigator, Swiss Federal Institute of Technology, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493297
- Sponsor's protocol ID
- ETH-FeVZ
- Status last verified
- Jan 2014
- First submitted
- 29 Nov 2011
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Walczyk T, Davidsson L, Rossander-Hulthen L, Hallberg L, Hurrell RF. No enhancing effect of vitamin A on iron absorption in humans. Am J Clin Nutr. 2003 Jan;77(1):144-9. doi: 10.1093/ajcn/77.1.144.
PubMed 12499334Garcia-Casal MN, Layrisse M, Solano L, Baron MA, Arguello F, Llovera D, Ramirez J, Leets I, Tropper E. Vitamin A and beta-carotene can improve nonheme iron absorption from rice, wheat and corn by humans. J Nutr. 1998 Mar;128(3):646-50. doi: 10.1093/jn/128.3.646.
PubMed 9482776Garcia-Casal MN. Carotenoids increase iron absorption from cereal based food in the human. Nutr Res 2006;26:340-4.
Layrisse M, Garcia-Casal MN, Solano L, et al. The role of vitamin A on the inhibitors of nonheme iron absorption: preliminary results. J Nutr Biochem 1997;8:61-7.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin A and Carotenoids on Iron Absorption
- ClinicalTrials.gov ID
- NCT01493297
- Acronym / sponsor ID
- ETH-FeVZ
- Conditions
- Iron Absorption
- Keywords
- Retinyl palmitate, beta-carotene, stable isotopes, radio isotopes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Instituto Venezolano de Investigaciones Cientificas
- Study start
- Sep 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 15 Dec 2011 (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 objective of this study is to investigate the effect of vitamin A and carotenoids on iron absorption in healthy subjects with low and normal vitamin A status. Vitamin A and carotenoids have been reported to enhance the nonheme iron absorption, but the results from human isotope studies are equivocal. Radio-iron studies in Venezuelan adults have consistently reported an increase in iron absorption, whereas stable and radio isotopes studies conducted in Sweden and Switzerland reported no influence. Differences in vitamin A status of the subjects may be a possible explanation for the contradictory findings. In this study, iron absorption will be measured from an iron-fortified maize bread meal with or without retinyl palmitate or β-carotene by using both stable- and radioactive-isotope techniques in Venezuelan women with a range of vitamin A status.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retinyl palmitate | Other | Other: Labeled iron solutionsLabeled iron as FeSO4 (4 mg) added to a test meal with or without retinyl palmitate (1000 RE) |
| Beta-carotene | Other | Other: Labeled iron solutionsLabeled iron as FeSO4 (4 mg) added to a test meal with or without beta-carotene (1000 RE) |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women 18-52 years old
- Body weight ≤ 70 kg
- Body mass index (BMI), 18.5-30 kg/m2
- Adequate vitamin A status (SR ≥ 0.7 μmol/L, n=20)
- Inadequate vitamin A status (SR < 0.7 μmol/L, n=20)
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Regular intake of medication (except oral contraceptives)
- Blood donation 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
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 solutionsLabeled iron as FeSO4 (4 mg/test meal) | Other | Beta-carotene, Retinyl palmitate |
Primary outcome
Fractional iron absorption
Time frame: 1 month after enrollment
Iron absorption will be estimated by measuring the erythrocyte incorporation of stable (57Fe/58Fe) and radio (55Fe/59Fe) iron isotopes labels given in test meals.
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 23 Jan 2014.
- Background: PubMed 12499334Walczyk T, Davidsson L, Rossander-Hulthen L, Hallberg L, Hurrell RF. No enhancing effect of vitamin A on iron absorption in humans. Am J Clin Nutr. 2003 Jan;77(1):144-9. doi: 10.1093/ajcn/77.1.144.
- Background: PubMed 9482776Garcia-Casal MN, Layrisse M, Solano L, Baron MA, Arguello F, Llovera D, Ramirez J, Leets I, Tropper E. Vitamin A and beta-carotene can improve nonheme iron absorption from rice, wheat and corn by humans. J Nutr. 1998 Mar;128(3):646-50. doi: 10.1093/jn/128.3.646.
- BackgroundGarcia-Casal MN. Carotenoids increase iron absorption from cereal based food in the human. Nutr Res 2006;26:340-4.
- BackgroundLayrisse M, Garcia-Casal MN, Solano L, et al. The role of vitamin A on the inhibitors of nonheme iron absorption: preliminary results. J Nutr Biochem 1997;8:61-7.
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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.
Maria Andersson, Dr principal investigator
Swiss Federal Institute of Technology, ETH Zurich
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 solutions in people with Iron Absorption, run by Swiss Federal Institute of Technology at 1 site in Venezuela.
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 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 23 Jan 2014. 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 Venezuela. 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?
Fractional iron absorption (time frame: 1 month after enrollment). 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 NCT01493297, which also lists 4 linked publications.
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 23 Jan 2014.