The Efficacy and Safety of Iron Supplementation

Imperial College London

Status: Unknown

Conditions: Healthy

Treatments: Dietary Supplement: Dietary supplement of iron; Drug: Ferrous sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT01590134

CLS/2012/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Control

No Intervention group

Description:

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

Iron control

Active Comparator group

Description:

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

Treatment:

Drug: Ferrous sulphate

Dietary supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: Dietary supplement of iron