The Efficacy and Safety of Iron Supplementation

NCT ID: NCT01590134

Last Updated: 2015-02-04

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type NO_INTERVENTION

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

Group Type ACTIVE_COMPARATOR

Ferrous sulphate

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Dietary supplement of iron

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Ferrous sulphate

200mg coated dried tablet containing 65mg elemental iron, equivalent to prophylactic daily dose as defined by the British National Formulary

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United Kingdom

References

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Further analyses are in progress for full manuscript.

Reference Type BACKGROUND

Gilson C, Busbridge M, Shovlin CL, Iron tablet profiling. Hematology Reports 2013: 5 (s1),30-1

Reference Type RESULT

Other Identifiers

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CLS/2012/1

Identifier Type: -

Identifier Source: org_study_id

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