Overview

This trial is active, not recruiting.

Condition healthy
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
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)
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
ferrous sulphate
200mg coated dried tablet containing 65mg elemental iron, equivalent to prophylactic daily dose as defined by the British National Formulary
(Experimental)
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 of iron
1 tablespoon of a dietary iron supplement containing 2.64mg of elemental iron

Primary Outcomes

Measure
Iron levels in blood tests
time frame: 48 hours

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Imperial College London.