Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
18 participants
INTERVENTIONAL
2012-03-31
2015-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
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
No interventions assigned to this group
Iron control
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
Ferrous sulphate
200mg coated dried tablet containing 65mg elemental iron, equivalent to prophylactic daily dose as defined by the British National Formulary
Dietary supplement
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
Dietary supplement of iron
1 tablespoon of a dietary iron supplement containing 2.64mg of elemental iron
Interventions
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Dietary supplement of iron
1 tablespoon of a dietary iron supplement containing 2.64mg of elemental iron
Ferrous sulphate
200mg coated dried tablet containing 65mg elemental iron, equivalent to prophylactic daily dose as defined by the British National Formulary
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Currently receiving iron supplements
3. Unable to provide informed consent
18 Years
80 Years
ALL
Yes
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Claire L Shovlin, PhD MA MB BChir FRCP
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Wellcome Trust-McMichael Clinical Research Facility, Imperial college London
London, , United Kingdom
Countries
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References
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Further analyses are in progress for full manuscript.
Gilson C, Busbridge M, Shovlin CL, Iron tablet profiling. Hematology Reports 2013: 5 (s1),30-1
Other Identifiers
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CLS/2012/1
Identifier Type: -
Identifier Source: org_study_id
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