HealthyNCT01590134
The Efficacy and Safety of Iron Supplementation
A study testing Dietary supplement of iron and Ferrous sulphate in people with Healthy, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Each year, 5 million packs of iron tablets are dispensed in England and Wales to treat anaemia due to iron deficiency. Iron tablets are not always easy to take. The investigators think that there could be ways to reduce the number of iron tablets needed, by increasing the dietary intake of iron. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dietary supplement of iron and Ferrous sulphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2012to Dec 2015
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be a healthy, consenting volunteer not currently receiving iron supplements.
Who cannot join
- Needle phobia
- Currently receiving iron supplements
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wellcome Trust-McMichael Clinical Research Facility, Imperial college London
London, W12 0NN
About this study
Official title: Pilot Studies on the Efficacy and Safety of Dietary Iron Supplementation
Each year, 5 million packs of iron tablets are dispensed in England and Wales to treat anaemia due to iron deficiency. Iron tablets are not always easy to take. The investigators think that there could be ways to reduce the number of iron tablets needed, by increasing the dietary intake of iron. In this study the investigators will assess the efficacy and safety of a dietary iron supplement compared to iron tablets using controls and new biomarkers.
Read the detailed description
18 healthy individuals will be randomised to one of three arms, and for two consecutive mornings, will receive either an iron tablet (ferrous sulphate 200mg), a dietary iron supplement, or no agent.
Blood and urine samples will be collected pre-dose, and at stated intervals 2.5, 4, 7, 24 and 48 hours post first dose.
The standard deviations of data obtained in this pilot study will be used to perform power calculations for our future studies in this field.
- Conditions
- Healthy
- Being tested
- Dietary supplement of iron, Ferrous sulphate
- Keywords
- volunteers, Pilot study, There are no pre registration evaluations., Inclusion criteria: to be a healthy, consenting volunteer not currently receiving iron supplements., Exclusion criteria: 1) Needle phobia; 2) Currently receiving iron supplements; 3) Unable to provide informed consent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement of ironDietary supplement
1 tablespoon of a dietary iron supplement containing 2.64mg of elemental iron
Ferrous sulphateDrug
200mg coated dried tablet containing 65mg elemental iron, equivalent to prophylactic daily dose as defined by the British National Formulary
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Following randomisation,to no active intervention, blood and urine samples will be collected at 6 stated intervals over a 48 hour period Total number of participants in arm = 6 |
| Iron control | Active comparator | Following randomisation, on each of two consecutive mornings, the participant will receive a single dose of ferrous sulphate 200mg. Blood and urine samples will be collected pre first dose, and at 5 further stated intervals over a 48 hour period.
Total number of participants in arm = 6 Receives: Drug: Ferrous sulphate |
| Dietary supplement | Experimental | Following randomisation, on each of two consecutive mornings, the participant will receive the experimental dietary iron supplement. Blood and urine samples will be collected pre first dose, and at 5 further stated intervals over a 48 hour period.
Toal participants in arm = 6 Receives: Dietary Supplement: Dietary supplement of iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron levels in blood tests
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire L Shovlin, PhD MA MB BChir FRCP, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590134
- Sponsor's protocol ID
- CLS/2012/1
- Status last verified
- Apr 2012
- First submitted
- 30 Apr 2012
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Further analyses are in progress for full manuscript.
Gilson C, Busbridge M, Shovlin CL, Iron tablet profiling. Hematology Reports 2013: 5 (s1),30-1
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Studies on the Efficacy and Safety of Dietary Iron Supplementation
- ClinicalTrials.gov ID
- NCT01590134
- Acronym / sponsor ID
- CLS/2012/1
- Conditions
- Healthy
- Keywords
- volunteers, Pilot study, There are no pre registration evaluations., Inclusion criteria: to be a healthy, consenting volunteer not currently receiving iron supplements., Exclusion criteria: 1) Needle phobia; 2) Currently receiving iron supplements; 3) Unable to provide informed consent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 2 May 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.
Each year, 5 million packs of iron tablets are dispensed in England and Wales to treat anaemia due to iron deficiency. Iron tablets are not always easy to take. The investigators think that there could be ways to reduce the number of iron tablets needed, by increasing the dietary intake of iron. In this study the investigators will assess the efficacy and safety of a dietary iron supplement compared to iron tablets using controls and new biomarkers.
Detailed description
18 healthy individuals will be randomised to one of three arms, and for two consecutive mornings, will receive either an iron tablet (ferrous sulphate 200mg), a dietary iron supplement, or no agent.
Blood and urine samples will be collected pre-dose, and at stated intervals 2.5, 4, 7, 24 and 48 hours post first dose.
The standard deviations of data obtained in this pilot study will be used to perform power calculations for our future studies in this field.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Following randomisation,to no active intervention, blood and urine samples will be collected at 6 stated intervals over a 48 hour period Total number of participants in arm = 6 |
| Iron control | Active comparator | Drug: Ferrous sulphateFollowing randomisation, on each of two consecutive mornings, the participant will receive a single dose of ferrous sulphate 200mg. Blood and urine samples will be collected pre first dose, and at 5 further stated intervals over a 48 hour period. Total number of participants in arm = 6 |
| Dietary supplement | Experimental | Dietary Supplement: Dietary supplement of ironFollowing randomisation, on each of two consecutive mornings, the participant will receive the experimental dietary iron supplement. Blood and urine samples will be collected pre first dose, and at 5 further stated intervals over a 48 hour period. Toal participants in arm = 6 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be a healthy, consenting volunteer not currently receiving iron supplements.
Key exclusion criteria (3 listed)
- Needle phobia
- Currently receiving iron supplements
- Unable to provide informed consent
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 |
|---|---|---|
| Dietary supplement of iron1 tablespoon of a dietary iron supplement containing 2.64mg of elemental iron | Dietary supplement | Dietary supplement |
| Ferrous sulphate200mg coated dried tablet containing 65mg elemental iron, equivalent to prophylactic daily dose as defined by the British National Formulary | Drug | Iron control |
Primary outcome
Iron levels in blood tests
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
- BackgroundFurther analyses are in progress for full manuscript.
- Results publicationGilson C, Busbridge M, Shovlin CL, Iron tablet profiling. Hematology Reports 2013: 5 (s1),30-1
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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.
Claire L Shovlin, PhD MA MB BChir FRCP principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement of iron and Ferrous sulphate in people with Healthy, run by Imperial College London 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Feb 2015. 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?
Results are not available in the source record.
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?
Iron levels in blood tests (time frame: 48 hours). 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 NCT01590134, which also lists 2 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 4 Feb 2015.