The Efficacy and Safety of Iron Supplementation

Study Overview
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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.

Official Title
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Pilot Studies on the Efficacy and Safety of Dietary Iron Supplementation

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Dietary supplement of iron
* Drug: Ferrous sulphate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be a healthy, consenting volunteer not currently receiving iron supplements. Exclusion Criteria: Needle phobia Currently receiving iron supplements Unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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 | Drug: Ferrous sulphate<br>* 200mg coated dried tablet containing 65mg elemental iron, equivalent to prophylactic daily dose as defined by the British National Formulary<br>|
| Experimental: Dietary supplement<br>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: Dietary supplement of iron<br>* 1 tablespoon of a dietary iron supplement containing 2.64mg of elemental iron<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron levels in blood tests |  | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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