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The Efficacy and Safety of Iron Supplementation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01590134
First received: April 30, 2012
Last updated: May 1, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Healthy
 Dietary Supplement: Dietary supplement of iron
Drug: Ferrous sulphate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Studies on the Efficacy and Safety of Dietary Iron Supplementation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Iron levels in blood tests [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control

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
Active Comparator: Iron control

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

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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590134

Locations
United Kingdom
Wellcome Trust-McMichael Clinical Research Facility, Imperial college London
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Claire L Shovlin, PhD MA MB BChir FRCP Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01590134     History of Changes
Other Study ID Numbers: CLS/2012/1
Study First Received: April 30, 2012
Last Updated: May 1, 2012
Health Authority: UK: National Research Ethics Service

Keywords provided by Imperial College London:
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

Additional relevant MeSH terms:
Iron
Trace Elements
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013