Brief Summary

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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.

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Study Primary Completion Date: December 2012

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

• Dietary Supplement: Dietary supplement of iron
  • 1 tablespoon of a dietary iron supplement containing 2.64mg of elemental iron
• Drug: Ferrous sulphate
  • 200mg coated dried tablet containing 65mg elemental iron, equivalent to prophylactic daily dose as defined by the British National Formulary

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: 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
• Active Comparator: 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
• Experimental: 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

Outcome Measures for this Clinical Trial

Primary Measures

• Iron levels in blood tests
  • Time Frame: 48 hours
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

• Lead Sponsor
  • Imperial College London
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Claire L Shovlin, PhD MA MB BChir FRCP, Principal Investigator, Imperial College London