The Efficacy and Safety of Iron Supplementation

Healthy Clinical Trial

Official title:

Pilot Studies on the Efficacy and Safety of Dietary Iron Supplementation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01590134
• Other study ID #: CLS/2012/1
• Status: Active, not recruiting
• Phase: N/A
• First received: April 30, 2012
• Last updated: February 3, 2015
• Start date: March 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2012
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: UK: National Research Ethics Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: December 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Dietary supplement of iron
1 tablespoon of a dietary iron supplement containing 2.64mg of elemental iron

Drug:
• Ferrous sulphate
200mg coated dried tablet containing 65mg elemental iron, equivalent to prophylactic daily dose as defined by the British National Formulary

Locations

Country	Name	City	State
United Kingdom	Wellcome Trust-McMichael Clinical Research Facility, Imperial college London	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Further analyses are in progress for full manuscript.

Gilson C, Busbridge M, Shovlin CL, Iron tablet profiling. Hematology Reports 2013: 5 (s1),30-1

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron levels in blood tests		48 hours	No