The Efficacy and Safety of Iron Supplementation

Pilot Studies on the Efficacy and Safety of Dietary Iron Supplementation

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01590134

Enrollment

Registered

2012-05-02

Start date

2012-03-31

Completion date

2015-12-31

Last updated

2015-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

volunteers, Pilot study, There are no pre registration evaluations., 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

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.

Interventions

DIETARY_SUPPLEMENTDietary supplement of iron

1 tablespoon of a dietary iron supplement containing 2.64mg of elemental iron

DRUGFerrous sulphate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Iron levels in blood tests	48 hours

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026