Iron-deficiency AnemiaEarly Phase 1NCT02498886
IHAT Absorption Kinetics
A Early Phase 1 study testing IHAT and Ferrous sulphate in people with Iron-deficiency Anemia, run by Medical Research Council at 1 site in The Gambia.
Trial summary
At MRC Human Nutrition Research, the investigators have developed an engineered analogue of the ferritin-core for safe and effective iron supplementation. Iron hydroxide adipate tartrate (IHAT) is a tartrate-modified, nano-disperse Fe(III) oxo-hydroxide, formed in an adipate buffer, with similar functional properties… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency Anemia
- What is being tested?
- IHAT and Ferrous sulphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteThe Gambia
- Study dates
- Aug 2015to Mar 2016
- Phase
- Early Phase 1
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pre-menopausal women apparently healthy (as judged by a study nurse at the screening day) with normal CRP (measured at screening).
- Non-pregnant (will be tested with a rapid pregnancy test) and non-lactating women.
- IDA arm: 9≤Hb≤11 g/dL and ferritin≤ 15 ng/ml
- Non-IDA arm: Hb>11 g/dL and ferritin> 15 ng/ml.
Who cannot join
- Malaria and other infections
- Severe anaemia (Hb<9 g/dL)
- CRP> 5 mg/L
- Chronic disease
- Currently participating in other iron intervention studies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Study to Determine Bioavailability and Transferrin Saturation Following a Single Dose of a Novel Iron Supplement (IHAT) in Gambian Women.
At MRC Human Nutrition Research, the investigators have developed an engineered analogue of the ferritin-core for safe and effective iron supplementation. Iron hydroxide adipate tartrate (IHAT) is a tartrate-modified, nano-disperse Fe(III) oxo-hydroxide, formed in an adipate buffer, with similar functional properties and small primary particle size (~2 nm) as the iron found in the ferritin core; it better mimics iron absorption from food than the non-physiological bolus doses of ferrous sulphate currently used.
This exploratory study will test the hypothesis that IHAT has equivalent bioavailability to ferrous sulphate but produces a less harmful post-ingestion rise in transferrin saturation. The design is a 3-arm (IDA, non-IDA and IDA-IHAT new manufacture), crossover, randomised, single-dose study.
Read more
Primary endpoint:
Relative bioavailability value of IHAT versus ferrous sulphate. This will be determined from the red blood cell incorporation of isotope-labelled iron 14 days following a single oral dose.
Secondary endpoints:
Serum iron at 0, 2, 4, 6 hours following a single dose of each iron compound. Transferrin saturation at 0, 2, 4, 6 hours following a single dose of each iron compound.
Plasma 58Fe and 57Fe at 0, 2, 4, 6 hours. Pathogen growth using ex vivo assays in serum collected from each subject at 0, 2, 4 and 6 hours following a single dose.
Read the detailed description
The study's main hypothesis is that IHAT will be bioavailable in pre-menopausal anaemic Gambian women and will lead to a lower serum iron and transferrin saturation increase than an equivalent dose of ferrous sulphate. Furthermore, the investigators hypothesize that IHAT will produce a less harmful post-ingestion rise in transferrin saturation, i.e. the serum collected from subjects following a single dose of IHAT will promote less pathogen growth in ex vivo assays than that collected following an equivalent dose of ferrous sulphate. Finally, based on previous animal data [5], the investigators hypothesize that IHAT absorption will be significantly higher in anaemic women compared to non-anaemic women, and that this will not be the case with ferrous sulphate.
This study is a cross-over, single-dose comparison against ferrous sulphate (standard of care) in anaemic and non-anaemic women. The iron single dosage for both compounds will be 60mg elemental iron equivalent and each compound will be labelled with a stable iron isotope. Outcomes will be: red blood cell incorporation of labelled iron, serum iron, transferrin saturation and pathogen growth in ex vivo serum assays.
Primary objective:
To determine iron bioavailability (i.e. red blood cell incorporation) from a single dose of IHAT versus ferrous sulphate in pre-menopausal Gambian women.
Secondary objective:
To determine serum iron absorption following a single dose of IHAT versus ferrous sulphate in pre-menopausal Gambian women.
To evaluate if a single-dose of IHAT produces a less harmful post-ingestion rise in transferrin saturation and serum iron than ferrous sulphate.
Each compound is labelled with a stable isotope of Fe so that its absorption can be determined from the red blood cell incorporation of the stable isotope 14 days after the single dose. This study is effectively a Phase 0 study (pharmacokinetics) with small numbers and because iron absorption varies from individual to individual, depending on their body iron needs and gastrointestinal digestion issues, it is more accurate to use each study subject as her own control. Therefore, each subject will ingest IHAT on one study day and the active treatment comparator on a separate day. The 2 study visits need to be 14 days apart to allow for red blood cell incorporation of the stable iron isotopes used to label the iron materials. This method is the gold standard to determine relative bioavailability values (RBV) of novel iron compounds (i.e. in relation to ferrous sulphate absorption) and allows an accurate determination of RBV of IHAT that otherwise would not be possible if we used a parallel study design with small numbers.
- Conditions
- Iron-deficiency Anemia
- Being tested
- IHAT, Ferrous sulphate
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IHATDietary supplement
Iron hydroxide adipate tartrate (IHAT): Single dose capsule containing IHAT equivalent to 60mg iron with 2 mg isotopically enriched with 58Fe.
Ferrous sulphateDietary supplement
Ferrous sulphate: Single dose capsule containing ferrous sulphate heptahydrate equivalent to 60 mg iron with 10 mg isotopically enriched with 57Fe.
| Study group | Role | What they receive |
|---|---|---|
| Iron deficient anaemic: IDA | Experimental | Iron deficient anaemic women.
Interventions: two iron supplements will be used:
IHAT- iron hydroxide adipate tartrate: an analogue of natural food iron. Ferrous sulphate- the gold standard for iron supplementation. For both the iron single-dose will be 60mg elemental iron equivalent.
Each compound will be labelled with a stable isotope of iron:
IHAT with 2 mg 58Fe and ferrous sulphate with 10 mg 57Fe.
1 capsule of each compound will be ingested with a full glass of water in two separate occasions, 14 days apart. Receives: Dietary Supplement: IHAT; Dietary Supplement: Ferrous sulphate |
| Iron sufficient: non-IDA | Experimental | Women that are not anaemic or iron deficient.
Interventions: two iron supplements will be used:
IHAT- iron hydroxide adipate tartrate: an analogue of natural food iron. Ferrous sulphate- the gold standard for iron supplementation. For both the iron single-dose will be 60mg elemental iron equivalent.
Each compound will be labelled with a stable isotope of iron:
IHAT with 2 mg 58Fe and ferrous sulphate with 10 mg 57Fe.
1 capsule of each compound will be ingested with a full glass of water in two separate occasions, 14 days apart. Receives: Dietary Supplement: IHAT; Dietary Supplement: Ferrous sulphate |
| Iron deficient anaemic (IDA): IHAT new manufacture | Experimental | Iron deficient anaemic women.
Interventions: two iron supplements will be used:
IHAT new manufacture- iron hydroxide adipate tartrate: an analogue of natural food iron.
Ferrous sulphate- the gold standard for iron supplementation. For both the iron single-dose will be 60mg elemental iron equivalent.
Each compound will be labelled with a stable isotope of iron:
IHAT with 2 mg 58Fe and ferrous sulphate with 10 mg 57Fe.
1 capsule of each compound will be ingested with a full glass of water in two separate occasions, 14 days apart. Receives: Dietary Supplement: IHAT; Dietary Supplement: Ferrous sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative bioavailability value of IHAT versus ferrous sulphate
This will be determined from the red blood cell incorporation of isotope-labelled iron 14 days following a single oral dose.
Measured: 14 days
Secondary outcomes (4)
Serum iron
Serum iron will be determined at 0, 2, 4, 6 hours following a single dose of each iron compounds (i.e. on days 1 and 14).
Measured: 6 hours
Transferrin saturation
Tsat will be determined at 0, 2, 4, 6 hours following a single dose of each iron compounds (i.e. on days 1 and 14).
Measured: 6 hours
Pathogen Growth
Pathogen growth will be determined using ex vivo assays in serum collected from each subject at 0, 2, 4 and 6 hours following a single dose of each compound (days 1 and 14).
Measured: 6 hours
Plasma iron
Plasma 58Fe and 57Fe will be determined at 0, 2, 4, 6 hours (on days 1 and 14).
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Iron-deficiency AnemiaStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Responsible party
- Principal investigator, dora pereira, Medical Research Council
- Investigators
- Dora I Pereira, PhD, Principal investigator, Medical Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498886
- Sponsor's protocol ID
- 1422
- Status last verified
- Feb 2017
- First submitted
- 13 Jul 2015
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Pereira DI, Bruggraber SF, Faria N, Poots LK, Tagmount MA, Aslam MF, Frazer DM, Vulpe CD, Anderson GJ, Powell JJ. Nanoparticulate iron(III) oxo-hydroxide delivers safe iron that is well absorbed and utilised in humans. Nanomedicine. 2014 Nov;10(8):1877-86. doi: 10.1016/j.nano.2014.06.012. Epub 2014 Jun 28.
PubMed 24983890Powell JJ, Bruggraber SF, Faria N, Poots LK, Hondow N, Pennycook TJ, Latunde-Dada GO, Simpson RJ, Brown AP, Pereira DI. A nano-disperse ferritin-core mimetic that efficiently corrects anemia without luminal iron redox activity. Nanomedicine. 2014 Oct;10(7):1529-38. doi: 10.1016/j.nano.2013.12.011. Epub 2014 Jan 4.
PubMed 24394211Aslam MF, Frazer DM, Faria N, Bruggraber SF, Wilkins SJ, Mirciov C, Powell JJ, Anderson GJ, Pereira DI. Ferroportin mediates the intestinal absorption of iron from a nanoparticulate ferritin core mimetic in mice. FASEB J. 2014 Aug;28(8):3671-8. doi: 10.1096/fj.14-251520. Epub 2014 Apr 28.
PubMed 24776745
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Determine Bioavailability and Transferrin Saturation Following a Single Dose of a Novel Iron Supplement (IHAT) in Gambian Women.
- ClinicalTrials.gov ID
- NCT02498886
- Acronym / sponsor ID
- 1422
- Conditions
- Iron-deficiency Anemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Medical Research CouncilOther government
- Study start
- Aug 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Jul 2015 (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.
At MRC Human Nutrition Research, the investigators have developed an engineered analogue of the ferritin-core for safe and effective iron supplementation. Iron hydroxide adipate tartrate (IHAT) is a tartrate-modified, nano-disperse Fe(III) oxo-hydroxide, formed in an adipate buffer, with similar functional properties and small primary particle size (~2 nm) as the iron found in the ferritin core; it better mimics iron absorption from food than the non-physiological bolus doses of ferrous sulphate currently used.
This exploratory study will test the hypothesis that IHAT has equivalent bioavailability to ferrous sulphate but produces a less harmful post-ingestion rise in transferrin saturation. The design is a 3-arm (IDA, non-IDA and IDA-IHAT new manufacture), crossover, randomised, single-dose study.
Primary endpoint:
Relative bioavailability value of IHAT versus ferrous sulphate. This will be determined from the red blood cell incorporation of isotope-labelled iron 14 days following a single oral dose.
Secondary endpoints:
Serum iron at 0, 2, 4, 6 hours following a single dose of each iron compound. Transferrin saturation at 0, 2, 4, 6 hours following a single dose of each iron compound.
Plasma 58Fe and 57Fe at 0, 2, 4, 6 hours. Pathogen growth using ex vivo assays in serum collected from each subject at 0, 2, 4 and 6 hours following a single dose.
Detailed description
The study's main hypothesis is that IHAT will be bioavailable in pre-menopausal anaemic Gambian women and will lead to a lower serum iron and transferrin saturation increase than an equivalent dose of ferrous sulphate. Furthermore, the investigators hypothesize that IHAT will produce a less harmful post-ingestion rise in transferrin saturation, i.e. the serum collected from subjects following a single dose of IHAT will promote less pathogen growth in ex vivo assays than that collected following an equivalent dose of ferrous sulphate. Finally, based on previous animal data [5], the investigators hypothesize that IHAT absorption will be significantly higher in anaemic women compared to non-anaemic women, and that this will not be the case with ferrous sulphate.
This study is a cross-over, single-dose comparison against ferrous sulphate (standard of care) in anaemic and non-anaemic women. The iron single dosage for both compounds will be 60mg elemental iron equivalent and each compound will be labelled with a stable iron isotope. Outcomes will be: red blood cell incorporation of labelled iron, serum iron, transferrin saturation and pathogen growth in ex vivo serum assays.
Primary objective:
To determine iron bioavailability (i.e. red blood cell incorporation) from a single dose of IHAT versus ferrous sulphate in pre-menopausal Gambian women.
Secondary objective:
To determine serum iron absorption following a single dose of IHAT versus ferrous sulphate in pre-menopausal Gambian women.
To evaluate if a single-dose of IHAT produces a less harmful post-ingestion rise in transferrin saturation and serum iron than ferrous sulphate.
Each compound is labelled with a stable isotope of Fe so that its absorption can be determined from the red blood cell incorporation of the stable isotope 14 days after the single dose. This study is effectively a Phase 0 study (pharmacokinetics) with small numbers and because iron absorption varies from individual to individual, depending on their body iron needs and gastrointestinal digestion issues, it is more accurate to use each study subject as her own control. Therefore, each subject will ingest IHAT on one study day and the active treatment comparator on a separate day. The 2 study visits need to be 14 days apart to allow for red blood cell incorporation of the stable iron isotopes used to label the iron materials. This method is the gold standard to determine relative bioavailability values (RBV) of novel iron compounds (i.e. in relation to ferrous sulphate absorption) and allows an accurate determination of RBV of IHAT that otherwise would not be possible if we used a parallel study design with small numbers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Iron deficient anaemic: IDA | Experimental | Dietary Supplement: IHAT, Dietary Supplement: Ferrous sulphateIron deficient anaemic women. Interventions: two iron supplements will be used: IHAT- iron hydroxide adipate tartrate: an analogue of natural food iron. Ferrous sulphate- the gold standard for iron supplementation. For both the iron single-dose will be 60mg elemental iron equivalent. Each compound will be labelled with a stable isotope of iron: IHAT with 2 mg 58Fe and ferrous sulphate with 10 mg 57Fe. 1 capsule of each compound will be ingested with a full glass of water in two separate occasions, 14 days apart. |
| Iron sufficient: non-IDA | Experimental | Dietary Supplement: IHAT, Dietary Supplement: Ferrous sulphateWomen that are not anaemic or iron deficient. Interventions: two iron supplements will be used: IHAT- iron hydroxide adipate tartrate: an analogue of natural food iron. Ferrous sulphate- the gold standard for iron supplementation. For both the iron single-dose will be 60mg elemental iron equivalent. Each compound will be labelled with a stable isotope of iron: IHAT with 2 mg 58Fe and ferrous sulphate with 10 mg 57Fe. 1 capsule of each compound will be ingested with a full glass of water in two separate occasions, 14 days apart. |
| Iron deficient anaemic (IDA): IHAT new manufacture | Experimental | Dietary Supplement: IHAT, Dietary Supplement: Ferrous sulphateIron deficient anaemic women. Interventions: two iron supplements will be used: IHAT new manufacture- iron hydroxide adipate tartrate: an analogue of natural food iron. Ferrous sulphate- the gold standard for iron supplementation. For both the iron single-dose will be 60mg elemental iron equivalent. Each compound will be labelled with a stable isotope of iron: IHAT with 2 mg 58Fe and ferrous sulphate with 10 mg 57Fe. 1 capsule of each compound will be ingested with a full glass of water in two separate occasions, 14 days apart. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pre-menopausal women apparently healthy (as judged by a study nurse at the screening day) with normal CRP (measured at screening).
- Non-pregnant (will be tested with a rapid pregnancy test) and non-lactating women.
- IDA arm: 9≤Hb≤11 g/dL and ferritin≤ 15 ng/ml
- Non-IDA arm: Hb>11 g/dL and ferritin> 15 ng/ml.
Key exclusion criteria (5 listed)
- Malaria and other infections
- Severe anaemia (Hb<9 g/dL)
- CRP> 5 mg/L
- Chronic disease
- Currently participating in other iron intervention studies.
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 |
|---|---|---|
| IHATIron hydroxide adipate tartrate (IHAT): Single dose capsule containing IHAT equivalent to 60mg iron with 2 mg isotopically enriched with 58Fe. | Dietary supplement | Iron deficient anaemic (IDA): IHAT new manufacture, Iron deficient anaemic: IDA, Iron sufficient: non-IDA |
| Ferrous sulphateFerrous sulphate: Single dose capsule containing ferrous sulphate heptahydrate equivalent to 60 mg iron with 10 mg isotopically enriched with 57Fe. | Dietary supplement | Iron deficient anaemic (IDA): IHAT new manufacture, Iron deficient anaemic: IDA, Iron sufficient: non-IDA |
Primary outcome
Relative bioavailability value of IHAT versus ferrous sulphate
Time frame: 14 days
This will be determined from the red blood cell incorporation of isotope-labelled iron 14 days following a single oral dose.
4 secondary outcomes
Serum iron
Time frame: 6 hours
Transferrin saturation
Time frame: 6 hours
Pathogen Growth
Time frame: 6 hours
Plasma iron
Time frame: 6 hours
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 6 Feb 2017.
- Background: PubMed 24983890Pereira DI, Bruggraber SF, Faria N, Poots LK, Tagmount MA, Aslam MF, Frazer DM, Vulpe CD, Anderson GJ, Powell JJ. Nanoparticulate iron(III) oxo-hydroxide delivers safe iron that is well absorbed and utilised in humans. Nanomedicine. 2014 Nov;10(8):1877-86. doi: 10.1016/j.nano.2014.06.012. Epub 2014 Jun 28.
- Background: PubMed 24394211Powell JJ, Bruggraber SF, Faria N, Poots LK, Hondow N, Pennycook TJ, Latunde-Dada GO, Simpson RJ, Brown AP, Pereira DI. A nano-disperse ferritin-core mimetic that efficiently corrects anemia without luminal iron redox activity. Nanomedicine. 2014 Oct;10(7):1529-38. doi: 10.1016/j.nano.2013.12.011. Epub 2014 Jan 4.
- Background: PubMed 24776745Aslam MF, Frazer DM, Faria N, Bruggraber SF, Wilkins SJ, Mirciov C, Powell JJ, Anderson GJ, Pereira DI. Ferroportin mediates the intestinal absorption of iron from a nanoparticulate ferritin core mimetic in mice. FASEB J. 2014 Aug;28(8):3671-8. doi: 10.1096/fj.14-251520. Epub 2014 Apr 28.
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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.
Dora I Pereira, PhD principal investigator
Medical Research Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing IHAT and Ferrous sulphate in people with Iron-deficiency Anemia, run by Medical Research Council at 1 site in The Gambia.
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 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 6 Feb 2017. 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 The Gambia. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Relative bioavailability value of IHAT versus ferrous sulphate (time frame: 14 days). 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 NCT02498886, which also lists 3 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 6 Feb 2017.