The Efficacy and Safety of Iron Supplementation

NCT01590134 | Unknown

• 1 other identifier: CLS/2012/1
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Iron levels in blood tests

  48 hours

Study Arms (3)

Control

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

Iron control

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

Drug: Ferrous sulphate

Dietary supplement

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: Dietary supplement of iron

Interventions

Dietary supplement of iron DIETARY_SUPPLEMENT

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

Dietary supplement

Ferrous sulphate DRUG

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

Iron control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be a healthy, consenting volunteer not currently receiving iron supplements.

You may not qualify if:

• Needle phobia
• Currently receiving iron supplements
• Unable to provide informed consent

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Wellcome Trust-McMichael Clinical Research Facility, Imperial college London

London, W12 0NN, United Kingdom

Location

Related Publications (2)

• Further analyses are in progress for full manuscript.

  BACKGROUND

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

  RESULT

MeSH Terms

Interventions

ferrous sulfate

Study Officials

• Claire L Shovlin, PhD MA MB BChir FRCP

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 2, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2015
• Last Updated: February 4, 2015

Record last verified: 2012-04

Locations

GB (1)