Iron DeficiencyNCT01528644
Iron & Alginate Study
A study testing alginate beads containing ferrous gluconate, ferrous gluconate in a capsule and ferrous gluconate in a capsule in presence of calcium in people with Iron Deficiency and Anaemia, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
Iron deficiency anaemia affects around two billion people worldwide. Food fortification with iron is a realistic way to combat this problem. Water soluble forms of iron are considered to be more bioavailable than nonsoluble iron compounds. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency, Anaemia
- What is being tested?
- alginate beads containing ferrous gluconate, ferrous gluconate in a capsule and ferrous gluconate in a capsule in presence of calcium
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2012to Jan 2013
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy women (aged 18-45) or male blood donors (aged 18-65)
- Serum ferritin value of ≥15 ≤ 60µg/L
- BMI >18.5 or < 30
- Willingness to consume jelly prepared with the use of gelatine from an animal source.
Who cannot join
- Diagnosed with a long-term illness requiring active treatment, e.g. diabetes, cancer, cardiovascular disease
- Currently smoking or stopped smoking in the last 12 months
- Previous or current GI disease
- Any significant co-morbidity
- Previous GI surgery
- Blood donation within the previous 3 months assuming that volume taken is above 500ml in a 4-month period
Show all 19Show fewer
- Blood transfusion within the last 3 months
- The results of the screening tests indicate unsuitability to take part in the study
- Related to someone in the study team i.e. spouse, partner or immediate family member
- 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 who are 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
- Unwillingness to consume jelly prepared with animal source gelatine
- 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 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
Clinical Research and Trials Unit (CRTU)/ Norfolk and Norwich University Hospital (NNUH)
Norwich, Norfolk, NR4 7TJ
About this study
Official title: Study to Measure the Absorption of Iron From Ferrous Gluconate Incorporated Into Alginate Beads.
Iron deficiency anaemia affects around two billion people worldwide. Food fortification with iron is a realistic way to combat this problem. Water soluble forms of iron are considered to be more bioavailable than nonsoluble iron compounds. However, the former often cause sensory problems when added to foods, while the latter cause fewer problems but are not generally well absorbed and are therefore ineffective as fortificants. A potential strategy for overcoming this problem is the use of water soluble iron compounds protected by a water resistant barrier, which will prevent potential organoleptic changes within fortified foods and protect the iron (from oxidation) through the digestion process thus increasing its availability. The investigators will use alginate, in the form of alginate beads, as a protective barrier for soluble iron gluconate. It has been shown that alginates bind divalent and trivalent cations and therefore may be a useful vehicle for soluble iron compounds to fortify foods.
The aim of this project is to measure the effect of alginate on iron absorption from ferrous gluconate and assess the potential modulating effect of calcium on iron absorption in the presence and absence of alginate.
Read the detailed description
This study is a randomised, single blinded, cross-over trial with participants randomly allocated into two groups: A (n= 8 volunteers) and B (n=8 volunteers). The study will include a total of four arms.
By administration of test meals #1 (iron in alginate beads) and #4 (iron in a capsule) the possible protective effect of alginate on iron absorption will be investigated. By administration of test meal #2 (iron in alginate beads + calcium capsule)and #3 (iron in a capsule + calcium in a capsule)the study will investigate whether alginates can bind calcium (a well-known iron inhibitor) in vivo, thus diminish the potential negative effect of calcium on iron absorption.
Only half (8) of the volunteers will undergo treatments including calcium. Therefore group A will undergo all 4 tests, whereas group B will undergo 2 out of 4 tests.
The four test meals will be administered a week apart following an overnight fast. On each occasion blood sampling will take place over a period of 6h with samples taken via a cannula at t=0, 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Serum samples will be analysed for iron content allowing calculation of iron absorption.
The assumptions made for the power calculation to estimate the number of volunteers are that a difference of 2.5% in iron absorption in the presence and absence of alginate ( test meal #1 and test meal #4) will be nutritionally significant. A minimum of 12 volunteers would be required to complete the study to detect a difference of 2.5% at a significance level of 0.05 for 80% power. A minimum of 8 volunteers would be required to detect a significant difference in iron absorption of 3.3% between a test meal containing 20mg of iron as iron gluconate with calcium and a test meal containing 20mg of iron as iron gluconate with calcium and alginate beads (test meals #2 and #3). This assumes a power of 80%, a level of significance of 0.05 and standard deviation of differences (within pairs) of 2.8%
- Conditions
- Iron Deficiency, Anaemia
- Being tested
- alginate beads containing ferrous gluconate, ferrous gluconate in a capsule, ferrous gluconate in a capsule in presence of calcium, alginate beads with ferrous gluconate in presence of calcium
- Keywords
- iron, fortification, alginate, iron deficiency
- 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.
alginate beads containing ferrous gluconateDietary supplement
Also called iron in alginate beads
After insertion of the cannula and collection of baseline blood sample a single dose of approximately 20mg of iron as ferrous gluconate incorporated into alginate beads (approximately 22.2g)and added to cola jelly (200ml) will be given to the volunteer together with 3 placebo capsules (each containing 50mg of dextrose)and cola drink (200ml). Once consumed, further blood samples will be taken at specified time points during 6 hour cannulation time. A minimum of 7 days wash out period will take place prior next intervention.
ferrous gluconate in a capsuleDietary supplement
Also called iron in capsule
After insertion of the cannula and collection of baseline blood sample a single dose of approximately 20mg of iron as ferrous gluconate in a capsule and 2 placebo capsules (each containing 50mg of dextrose) followed by a cola jelly (200ml)and cola drink (200ml) will be given to the volunteer. Once consumed, further blood samples will be taken at specified time points during 6 hour cannulation time. A minimum of 7 days wash out period will take place prior next intervention.
ferrous gluconate in a capsule in presence of calciumDietary supplement
Also called iron in a capsule followed by calcium phosphate
After insertion of the cannula and collection of baseline blood sample a single dose of approximately 20mg of iron as ferrous gluconate in a capsule together with 2 calcium capsules (each containing 300mg of calcium phosphate)followed by cola jelly (200ml) and cola drink(200ml)will be given to the volunteer . Once consumed, further blood samples will be taken at specified time points during 6 hour cannulation time. A minimum of 7 days wash out period will take place prior next intervention.
alginate beads with ferrous gluconate in presence of calciumDietary supplement
Also called iron in alginate beads in presence of calcium phosphate
After insertion of the cannula and collection of baseline blood sample a single dose of approximately 20mg of iron as ferrous gluconate incorporated into alginate beads (approximately 22.2g)and added to cola jelly (200ml) will be given to the volunteer together with 2 calcium capsules (each containing 300mg of calcium as calcium phosphate, 1 placebo capsule (containing 50mg of dextrose)and cola drink (200ml). Once consumed, further blood samples will be taken at specified time points during 6 hour cannulation time. A minimum of 7 days wash out period will take place prior next intervention.
| Study group | Role | What they receive |
|---|---|---|
| Iron in beads | Experimental | All experimental days will be exactly the same with the exception of the test meal administered to the volunteer. Volunteers will undergo a 10 hour overnight fast from 10:00pm, then they will be asked to attend the CRTU at approximately 8:00 am the following morning. A nurse will take and record the volunteer's blood pressure and if within the range an intravenous (i.v.) cannula will be inserted into a vein in one of the volunteer's arms. The cannula will remain in situ for six hours. After the first blood sample (t=0) will be taken, volunteers will consume one out of 4 test meals. After consumption further blood samples will be collected at: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Blood samples will subsequently be analysed for serum iron concentrations. Receives: Dietary Supplement: alginate beads containing ferrous gluconate |
| Iron in capsule | Experimental | All experimental days will be exactly the same with the exception of the test meal administered to the volunteer. Volunteers will undergo a 10 hour overnight fast from 10:00pm, then they will be asked to attend the CRTU at approximately 8:00 am the following morning. A nurse will take and record the volunteer's blood pressure and if within the range an intravenous (i.v.) cannula will be inserted into a vein in one of the volunteer's arms. The cannula will remain in situ for six hours. After the first blood sample (t=0) will be taken, volunteers will consume one out of 4 test meals. After consumption further blood samples will be collected at: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Blood samples will subsequently be analysed for serum iron concentrations. Receives: Dietary Supplement: ferrous gluconate in a capsule |
| Iron in beads in presence of calcium | Experimental | All experimental days will be exactly the same with the exception of the test meal administered to the volunteer. Volunteers will undergo a 10 hour overnight fast from 10:00pm, then they will be asked to attend the CRTU at approximately 8:00 am the following morning. A nurse will take and record the volunteer's blood pressure and if within the range an intravenous (i.v.) cannula will be inserted into a vein in one of the volunteer's arms. The cannula will remain in situ for six hours. After the first blood sample (t=0) will be taken, volunteers will consume one out of 4 test meals. After consumption further blood samples will be collected at: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Blood samples will subsequently be analysed for serum iron concentrations. Receives: Dietary Supplement: alginate beads with ferrous gluconate in presence of calcium |
| Iron in capsule in presence of calcium | Experimental | All experimental days will be exactly the same with the exception of the test meal administered to the volunteer. Volunteers will undergo a 10 hour overnight fast from 10:00pm, then they will be asked to attend the CRTU at approximately 8:00 am the following morning. A nurse will take and record the volunteer's blood pressure and if within the range an intravenous (i.v.) cannula will be inserted into a vein in one of the volunteer's arms. The cannula will remain in situ for six hours. After the first blood sample (t=0) will be taken, volunteers will consume one out of 4 test meals. After consumption further blood samples will be collected at: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Blood samples will subsequently be analysed for serum iron concentrations. Receives: Dietary Supplement: ferrous gluconate in a capsule in presence of calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in iron absorption
Iron absorption (by measuring iron appearance in the serum)will be measured on four occasions with a week in between each measurement. Absorption will be assessed in response to four test meals as follows: unprotected ferrous gluconate, iron gluconate incorporated into alginate beads,ferrous gluconate incorporated into alginate beads given with calcium, and unprotected ferrous gluconate given with calcium.
Measured: Four weekly measurements over a period of three weeks (6h Cannulation, baseline blood sample (t=0). Test meal 1, followed by blood sample collection at 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Removal of the cannula)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- Quadram Institute Bioscience
- Responsible party
- Sponsor
- Investigators
- Susan Fairweather-Tait, Professor, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528644
- Sponsor's protocol ID
- BBSRC grant:BB/G0055833/1
- Other IDs
- 2011/2012-05
- Status last verified
- Feb 2013
- First submitted
- 17 Jan 2012
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wawer AA, Harvey LJ, Dainty JR, Perez-Moral N, Sharp P, Fairweather-Tait SJ. Alginate inhibits iron absorption from ferrous gluconate in a randomized controlled trial and reduces iron uptake into Caco-2 cells. PLoS One. 2014 Nov 12;9(11):e112144. doi: 10.1371/journal.pone.0112144. eCollection 2014.
PubMed 25391138
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Measure the Absorption of Iron From Ferrous Gluconate Incorporated Into Alginate Beads.
- ClinicalTrials.gov ID
- NCT01528644
- Acronym / sponsor ID
- BBSRC grant:BB/G0055833/1
- Conditions
- Iron Deficiency, Anaemia
- Keywords
- iron, fortification, alginate, iron deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- Quadram Institute Bioscience
- Study start
- Feb 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Feb 2012 (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.
Iron deficiency anaemia affects around two billion people worldwide. Food fortification with iron is a realistic way to combat this problem. Water soluble forms of iron are considered to be more bioavailable than nonsoluble iron compounds. However, the former often cause sensory problems when added to foods, while the latter cause fewer problems but are not generally well absorbed and are therefore ineffective as fortificants. A potential strategy for overcoming this problem is the use of water soluble iron compounds protected by a water resistant barrier, which will prevent potential organoleptic changes within fortified foods and protect the iron (from oxidation) through the digestion process thus increasing its availability. The investigators will use alginate, in the form of alginate beads, as a protective barrier for soluble iron gluconate. It has been shown that alginates bind divalent and trivalent cations and therefore may be a useful vehicle for soluble iron compounds to fortify foods.
The aim of this project is to measure the effect of alginate on iron absorption from ferrous gluconate and assess the potential modulating effect of calcium on iron absorption in the presence and absence of alginate.
Detailed description
This study is a randomised, single blinded, cross-over trial with participants randomly allocated into two groups: A (n= 8 volunteers) and B (n=8 volunteers). The study will include a total of four arms.
By administration of test meals #1 (iron in alginate beads) and #4 (iron in a capsule) the possible protective effect of alginate on iron absorption will be investigated. By administration of test meal #2 (iron in alginate beads + calcium capsule)and #3 (iron in a capsule + calcium in a capsule)the study will investigate whether alginates can bind calcium (a well-known iron inhibitor) in vivo, thus diminish the potential negative effect of calcium on iron absorption.
Only half (8) of the volunteers will undergo treatments including calcium. Therefore group A will undergo all 4 tests, whereas group B will undergo 2 out of 4 tests.
The four test meals will be administered a week apart following an overnight fast. On each occasion blood sampling will take place over a period of 6h with samples taken via a cannula at t=0, 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Serum samples will be analysed for iron content allowing calculation of iron absorption.
The assumptions made for the power calculation to estimate the number of volunteers are that a difference of 2.5% in iron absorption in the presence and absence of alginate ( test meal #1 and test meal #4) will be nutritionally significant. A minimum of 12 volunteers would be required to complete the study to detect a difference of 2.5% at a significance level of 0.05 for 80% power. A minimum of 8 volunteers would be required to detect a significant difference in iron absorption of 3.3% between a test meal containing 20mg of iron as iron gluconate with calcium and a test meal containing 20mg of iron as iron gluconate with calcium and alginate beads (test meals #2 and #3). This assumes a power of 80%, a level of significance of 0.05 and standard deviation of differences (within pairs) of 2.8%
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Iron in beads | Experimental | Dietary Supplement: alginate beads containing ferrous gluconateAll experimental days will be exactly the same with the exception of the test meal administered to the volunteer. Volunteers will undergo a 10 hour overnight fast from 10:00pm, then they will be asked to attend the CRTU at approximately 8:00 am the following morning. A nurse will take and record the volunteer's blood pressure and if within the range an intravenous (i.v.) cannula will be inserted into a vein in one of the volunteer's arms. The cannula will remain in situ for six hours. After the first blood sample (t=0) will be taken, volunteers will consume one out of 4 test meals. After consumption further blood samples will be collected at: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Blood samples will subsequently be analysed for serum iron concentrations. |
| Iron in capsule | Experimental | Dietary Supplement: ferrous gluconate in a capsuleAll experimental days will be exactly the same with the exception of the test meal administered to the volunteer. Volunteers will undergo a 10 hour overnight fast from 10:00pm, then they will be asked to attend the CRTU at approximately 8:00 am the following morning. A nurse will take and record the volunteer's blood pressure and if within the range an intravenous (i.v.) cannula will be inserted into a vein in one of the volunteer's arms. The cannula will remain in situ for six hours. After the first blood sample (t=0) will be taken, volunteers will consume one out of 4 test meals. After consumption further blood samples will be collected at: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Blood samples will subsequently be analysed for serum iron concentrations. |
| Iron in beads in presence of calcium | Experimental | Dietary Supplement: alginate beads with ferrous gluconate in presence of calciumAll experimental days will be exactly the same with the exception of the test meal administered to the volunteer. Volunteers will undergo a 10 hour overnight fast from 10:00pm, then they will be asked to attend the CRTU at approximately 8:00 am the following morning. A nurse will take and record the volunteer's blood pressure and if within the range an intravenous (i.v.) cannula will be inserted into a vein in one of the volunteer's arms. The cannula will remain in situ for six hours. After the first blood sample (t=0) will be taken, volunteers will consume one out of 4 test meals. After consumption further blood samples will be collected at: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Blood samples will subsequently be analysed for serum iron concentrations. |
| Iron in capsule in presence of calcium | Experimental | Dietary Supplement: ferrous gluconate in a capsule in presence of calciumAll experimental days will be exactly the same with the exception of the test meal administered to the volunteer. Volunteers will undergo a 10 hour overnight fast from 10:00pm, then they will be asked to attend the CRTU at approximately 8:00 am the following morning. A nurse will take and record the volunteer's blood pressure and if within the range an intravenous (i.v.) cannula will be inserted into a vein in one of the volunteer's arms. The cannula will remain in situ for six hours. After the first blood sample (t=0) will be taken, volunteers will consume one out of 4 test meals. After consumption further blood samples will be collected at: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Blood samples will subsequently be analysed for serum iron concentrations. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Apparently healthy women (aged 18-45) or male blood donors (aged 18-65)
- Serum ferritin value of ≥15 ≤ 60µg/L
- BMI >18.5 or < 30
- Willingness to consume jelly prepared with the use of gelatine from an animal source.
Key exclusion criteria (19 listed)
- Diagnosed with a long-term illness requiring active treatment, e.g. diabetes, cancer, cardiovascular disease
- Currently smoking or stopped smoking in the last 12 months
- Previous or current GI disease
- Any significant co-morbidity
- Previous GI surgery
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 |
|---|---|---|
| alginate beads containing ferrous gluconateAlso: iron in alginate beadsAfter insertion of the cannula and collection of baseline blood sample a single dose of approximately 20mg of iron as ferrous gluconate incorporated into alginate beads (approximately 22.2g)and added to cola jelly (200ml) will be given to the volunteer together with 3 placebo capsules (each containing 50mg of dextrose)and cola drink (200ml). Once consumed, further blood samples will be taken at specified time points during 6 hour cannulation time. A minimum of 7 days wash out period will take place prior next intervention. | Dietary supplement | Iron in beads |
| ferrous gluconate in a capsuleAlso: iron in capsuleAfter insertion of the cannula and collection of baseline blood sample a single dose of approximately 20mg of iron as ferrous gluconate in a capsule and 2 placebo capsules (each containing 50mg of dextrose) followed by a cola jelly (200ml)and cola drink (200ml) will be given to the volunteer. Once consumed, further blood samples will be taken at specified time points during 6 hour cannulation time. A minimum of 7 days wash out period will take place prior next intervention. | Dietary supplement | Iron in capsule |
| ferrous gluconate in a capsule in presence of calciumAlso: iron in a capsule followed by calcium phosphateAfter insertion of the cannula and collection of baseline blood sample a single dose of approximately 20mg of iron as ferrous gluconate in a capsule together with 2 calcium capsules (each containing 300mg of calcium phosphate)followed by cola jelly (200ml) and cola drink(200ml)will be given to the volunteer . Once consumed, further blood samples will be taken at specified time points during 6 hour cannulation time. A minimum of 7 days wash out period will take place prior next intervention. | Dietary supplement | Iron in capsule in presence of calcium |
| alginate beads with ferrous gluconate in presence of calciumAlso: iron in alginate beads in presence of calcium phosphateAfter insertion of the cannula and collection of baseline blood sample a single dose of approximately 20mg of iron as ferrous gluconate incorporated into alginate beads (approximately 22.2g)and added to cola jelly (200ml) will be given to the volunteer together with 2 calcium capsules (each containing 300mg of calcium as calcium phosphate, 1 placebo capsule (containing 50mg of dextrose)and cola drink (200ml). Once consumed, further blood samples will be taken at specified time points during 6 hour cannulation time. A minimum of 7 days wash out period will take place prior next intervention. | Dietary supplement | Iron in beads in presence of calcium |
Primary outcome
Change in iron absorption
Time frame: Four weekly measurements over a period of three weeks (6h Cannulation, baseline blood sample (t=0). Test meal 1, followed by blood sample collection at 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Removal of the cannula)
Iron absorption (by measuring iron appearance in the serum)will be measured on four occasions with a week in between each measurement. Absorption will be assessed in response to four test meals as follows: unprotected ferrous gluconate, iron gluconate incorporated into alginate beads,ferrous gluconate incorporated into alginate beads given with calcium, and unprotected ferrous gluconate given with calcium.
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 1 Mar 2013.
- Derived from this study: PubMed 25391138Wawer AA, Harvey LJ, Dainty JR, Perez-Moral N, Sharp P, Fairweather-Tait SJ. Alginate inhibits iron absorption from ferrous gluconate in a randomized controlled trial and reduces iron uptake into Caco-2 cells. PLoS One. 2014 Nov 12;9(11):e112144. doi: 10.1371/journal.pone.0112144. eCollection 2014.
Related trials for Iron Deficiency
Active, not recruitingObservational study
Ethnic Differences in Iron Absorption (FeGenes)
Anemia, Iron Deficiency, Iron Overload
Active, not recruitingObservational study
Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption
Anemia, Iron Deficiency, Iron Overload
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
Active, not recruiting
A Study to Evaluate the Effects of a Beef Liver Supplement on Energy, Mood, and Mental Clarity
Fatigue, Low Mood
Recruiting
Safety and Efficacy of Iron Prophylaxis With on Iron Homeostasis in Healthy Pregnant Women
Iron Deficiency Anemia in Pregnancy, Iron Deficiency in Pregnancy
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 Fairweather-Tait, Professor 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 alginate beads containing ferrous gluconate, ferrous gluconate in a capsule and ferrous gluconate in a capsule in presence of calcium in people with Iron Deficiency and Anaemia, run by University of East Anglia 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 19 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 1 Mar 2013. 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?
Change in iron absorption (time frame: Four weekly measurements over a period of three weeks (6h Cannulation, baseline blood sample (t=0). Test meal 1, followed by blood sample collection at 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Removal of the cannula)). 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 NCT01528644, which also lists 1 linked publication.
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 1 Mar 2013; AzTrials last refreshed its copy on 28 Oct 2026.