Iron DeficiencyNCT00474682
Relative Bioavailability of Ferric Pyrophosphate From an Apple Juice Drink
A study testing Micronized dispersible ferric pyrophosphate in people with Iron Deficiency, run by Quadram Institute Bioscience at 1 site in United Kingdom.
Trial summary
The aim of this study is to find out how well iron is absorbed when a newly developed form of ferric pyrophosphate is added to a commercial apple juice drink. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- Micronized dispersible ferric pyrophosphate
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento not given
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women
- Age >18 and <65
- BMI >18.5 and <35
- Serum ferritin value of =12μg/L and =50μg/L
Who cannot join
- Men
- Age < 18 or >65
- BMI <18.5 or >35
- Serum ferritin value of <12μg/L or >50μg/L
- Volunteers will be excluded if they are found to have depressed or elevated blood pressure measurements (<90/50 or<95/50 if symptomatic or >160/100)
- Diagnosed with a long-term illness requiring active treatment, e.g. diabetes, cancer, cardiovascular disease
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- Gastrointestinal disease (excluding hiatus hernia unless symptomatic)
- Regular prescribed medication that may interfere with iron metabolism
- Regular use of antacids and laxatives (at least once a week)
- Women who are pregnant or less than 12 months since giving birth
- Women breast feeding
- Vitamin supplements with or without minerals if taken more than once a week, and unwillingness to discontinue occasional use for the duration of study
- Unwillingness to discontinue use of herbal supplements for the duration of study
- Use of antibiotics within four weeks prior to study start
- Parallel participation in another study which involves dietary interventions or sampling of blood that may increase the volume taken above 500ml in a 4-month period.
- Asthma requiring treatment within the last two years
- Results of clinical screening which indicate, or are judged by the HNU Medical advisor to be indicative of a health problem which could compromise the well-being of the volunteer if they participated or which would affect the study data.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Food Research
Norwich, Norfolk, NR4 6JF
About this study
The aim of this study is to find out how well iron is absorbed when a newly developed form of ferric pyrophosphate is added to a commercial apple juice drink.
Read the detailed description
Micronized dispersible ferric pyrophosphate (MDFP) is an iron compound that has been reported to be highly bioavailable and likely to cause few sensory problems when added to food. It is therefore a potentially effective iron additive for the food industry and is particularly formulated for adding to liquids. A randomized cross-over trial will be undertaken to compare the absorption of iron added to a commercial apple juice drink as MDFP with iron added as ferrous sulphate. The null hypothesis is that absorption of iron added as MDFP is not different to absorption from iron added as ferrous sulphate.
The study population will consist of 16 women (age 18-65) with iron stores at the lower end of the normal range. This group will efficiently absorb bioavailable iron and will be sensitive to differences in bioavailability between different forms of iron. Test drinks containing added iron, labelled with stable isotopes of iron (Fe-57 or Fe-58), will be consumed on two consecutive days. Iron absorption from the drinks will be determined using the erythrocyte incorporation technique. A baseline blood sample will be taken prior to consuming the test drinks and then a second blood sample will be taken 14 days after the last test drink. Iron absorption will be calculated from the isotopic enrichment of the final blood sample, assuming that 80% of absorbed iron is incorporated into red blood cells. The order in which the volunteers will be given the MDFP or ferrous sulphate will be randomised.
- Conditions
- Iron Deficiency
- Being tested
- Micronized dispersible ferric pyrophosphate
- Keywords
- ferric pyrophosphate, iron bioavailability, fortification,
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronized dispersible ferric pyrophosphateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative bioavailability of Micronized dispersible ferric pyrophosphate added to apple juice
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficiencyStudies 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
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Collaborators
- The Coca-Cola Company
- Investigators
- Susan J Fairweather-Tait, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474682
- Sponsor's protocol ID
- IFR04/2006
- Status last verified
- May 2007
- First submitted
- 16 May 2007
- Last updated
- 3 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of Ferric Pyrophosphate From an Apple Juice Drink
- ClinicalTrials.gov ID
- NCT00474682
- Acronym / sponsor ID
- IFR04/2006
- Conditions
- Iron Deficiency
- Keywords
- ferric pyrophosphate, iron bioavailability, fortification,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Collaborators
- The Coca-Cola Company
- First posted
- 17 May 2007 (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 aim of this study is to find out how well iron is absorbed when a newly developed form of ferric pyrophosphate is added to a commercial apple juice drink.
Detailed description
Micronized dispersible ferric pyrophosphate (MDFP) is an iron compound that has been reported to be highly bioavailable and likely to cause few sensory problems when added to food. It is therefore a potentially effective iron additive for the food industry and is particularly formulated for adding to liquids. A randomized cross-over trial will be undertaken to compare the absorption of iron added to a commercial apple juice drink as MDFP with iron added as ferrous sulphate. The null hypothesis is that absorption of iron added as MDFP is not different to absorption from iron added as ferrous sulphate.
The study population will consist of 16 women (age 18-65) with iron stores at the lower end of the normal range. This group will efficiently absorb bioavailable iron and will be sensitive to differences in bioavailability between different forms of iron. Test drinks containing added iron, labelled with stable isotopes of iron (Fe-57 or Fe-58), will be consumed on two consecutive days. Iron absorption from the drinks will be determined using the erythrocyte incorporation technique. A baseline blood sample will be taken prior to consuming the test drinks and then a second blood sample will be taken 14 days after the last test drink. Iron absorption will be calculated from the isotopic enrichment of the final blood sample, assuming that 80% of absorbed iron is incorporated into red blood cells. The order in which the volunteers will be given the MDFP or ferrous sulphate will be randomised.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women
- Age >18 and <65
- BMI >18.5 and <35
- Serum ferritin value of =12μg/L and =50μg/L
Key exclusion criteria (17 listed)
- Men
- Age < 18 or >65
- BMI <18.5 or >35
- Serum ferritin value of <12μg/L or >50μg/L
- Volunteers will be excluded if they are found to have depressed or elevated blood pressure measurements (<90/50 or<95/50 if symptomatic or >160/100)
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 |
|---|---|---|
| Micronized dispersible ferric pyrophosphate | Drug | – |
Primary outcome
Relative bioavailability of Micronized dispersible ferric pyrophosphate added to apple juice
Time frame: 18 months
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 3 Dec 2008.
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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.
Susan J Fairweather-Tait principal investigator
University of East Anglia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micronized dispersible ferric pyrophosphate in people with Iron Deficiency, run by Quadram Institute Bioscience at 1 site in United Kingdom.
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 4 inclusion and 17 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 3 Dec 2008. 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 United Kingdom. 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?
Relative bioavailability of Micronized dispersible ferric pyrophosphate added to apple juice (time frame: 18 months). 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 3 Dec 2008.