The Efficacy and Safety of Iron Supplementation

Not Applicable

• Conditions: Healthy
• Interventions: Dietary Supplement: Dietary supplement of iron; Drug: Ferrous sulphate

• Registration Number: NCT01590134
• Lead Sponsor: Imperial College London

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-03
• Status Verified: 2012-04
• Study First Submitted: 2012-04-30
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-02
• Primary Completion: 2012-12
• Last Update Submitted: 2015-02-03
• Last Update Posted: 2015-02-04
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary supplement	Dietary supplement of iron	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
Iron control	Ferrous sulphate	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

Primary Outcome Measures

Name	Time	Method
Iron levels in blood tests	48 hours

Trial Locations

Locations (1)

Wellcome Trust-McMichael Clinical Research Facility, Imperial college London; 🇬🇧 London, United Kingdom