Healthy Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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