The Efficacy and Safety of Iron Supplementation
This trial is active, not recruiting.
|Treatments||dietary supplement of iron, ferrous sulphate|
|Sponsor||Imperial College London|
|Start date||March 2012|
|End date||December 2012|
|Trial size||18 participants|
|Trial identifier||NCT01590134, CLS/2012/1|
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.
|Endpoint classification||bio-equivalence study|
|Intervention model||parallel assignment|
Iron levels in blood tests
time frame: 48 hours
Male or female participants from 18 years up to 80 years old.
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
|Official title||Pilot Studies on the Efficacy and Safety of Dietary Iron Supplementation|
|Principal investigator||Claire L Shovlin, PhD MA MB BChir FRCP|
|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.|
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