- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01991600
A Pilot Study to Assess the Influence of Dietary Organic Acids on Iron Absorption.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study was a first-in-human iron absorption study of ferric iron oxide-organic acid preparations (Fe-OAs). The study design was cross-over, single-dose, single-blinded comparison against standard-of-care therapy (namely ferrous sulphate) in mildly iron deficient anaemic women. Methyl-cellulose capsules containing single doses of Fe-OAs (60 mg elemental iron equivalent) were given to four subjects per test mixture to determine iron absorption and bioavailability. The study was initially designed in 2 parts (A and B). Part A was an iterative process to determine the best choice of organic acids and the optimal ratio of iron to organic acid that allowed efficient iron absorption, while part B was a comparison of absorption of the two most promising Fe-OA preparations against the standard-of-care therapy (namely ferrous sulphate). Following this iterative-based study we had a candidate Fe-OA preparation that showed nearly equivalent bioavailability to ferrous sulphate and we decided to stop the study at the end of Part A.
On day 1 of the study (Part A), the participants were given one methyl-cellulose capsule containing one of the Fe-OA preparations to be taken on an empty stomach or with a light breakfast consisting of water and 2 slices of white bread with jam. Participants were blinded to which test preparation they received. Serial serum iron levels were obtained at baseline and then 30, 60, 90, 120, 180, 210 and 240 minutes after ingestion of the iron dosage. Fourteen days later the participants returned for the second study visit where they ingested one ferrous sulphate tablet with a light breakfast, and the same visit protocol was followed. Each subject acted as her own control.
The bioavailability of iron from the Fe-OA preparations was determined by measuring erythrocyte incorporation of labelled iron 14 days following a single oral dose. Each Fe-OA preparation was labelled with 2 mg of the stable isotope 58Fe per single dose of the Fe-OA material. Ferrous sulphate was used as a reference for oral iron therapy and to determine individuals who were non-iron absorbers. Non-iron absorbers were defined as those who had no significant net area under the curve (AUC) for serum iron following ferrous sulphate oral ingestion (i.e. this was defined as a serum iron increase ≤ 5 μM). The data obtained for these individuals were excluded from the final analysis.
The bioavailability of ferrous sulphate was determined using short-term changes in serum iron levels using published algorithms.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Cambridgeshire
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Cambridge, Cambridgeshire, United Kingdom, CB1 9NL
- MRC Human Nutrition Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female aged 18-45 years.
Low iron stores based on one of the following criteria:
(I) Mild iron deficiency anaemia defined as haemoglobin between 10-11.9 g/dL plus either a serum ferritin less than 20 μg/L or transferrin saturation < 10% or (II) iron deficiency defined as a serum ferritin less than 12 μg/L.
Exclusion Criteria:
- pregnancy and lactation
- surgery in the past three months
- cancer in last ten years
- known chronic infection
- chronic inflammation
- moderate or severe anaemia
- known cardiovascular disease
- chronic respiratory disease.
- history of hereditary haemochromatosis or haemoglobinopathies
- current proton pump inhibitor medication
- blood donation/heavy blood loss in the last 3 months
- iron supplementation in the past 1 month
- chronic liver disease
- renal disease
- Coeliac Disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Ferrous Sulphate
The active comparator was the standard-of-care therapy for iron deficiency anaemia (namely ferrous sulphate).
Generic uncoated ferrous sulphate tablets BP 300 mg containing 60mg elemental iron were purchased from a local pharmacy.
The route of administration was oral.
Each participant ingested one ferrous sulphate tablet (60 mg Fe) on one of the study visits.
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Experimental: ferric iron oxide-organic acid (Fe-OA)
Fifteen different ferric iron oxide-organic acid preparations were investigated.
Most organic acids used were generally recognised as safe (GRAS) and all were used at dietary equivalent levels.
The dosage was 58 ± 6 mg elemental iron equivalent (average of all compounds).
The route of administration was oral using methyl-cellulose capsules.
On one of the study visits, each participant ingested a single dose, equivalent to ca. 60 mg iron, of the Fe-OA preparation allocated to her.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Iron Bioavailability
Time Frame: 14 days
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The primary outcome was bioavailability of iron from ferric iron oxide-organic acid preparations (Fe-OA) as measured by erythrocyte incorporation of labelled iron (58Fe).
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14 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Iron absorption
Time Frame: 4 hours
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The secondary outcomes were total iron absorption and the rates of iron absorption in the 4 hours following the ingestion of the ferric iron oxide-organic acid preparations (Fe-OA)and the active comparator (namely ferrous sulphate).
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4 hours
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jonathan Powell, PhD, Medical Research Council
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6129
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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