A Pilot Study to Assess the Influence of Dietary Organic Acids on Iron Absorption.
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|ClinicalTrials.gov Identifier: NCT01991600|
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency Anaemia||Dietary Supplement: ferrous sulphate Dietary Supplement: ferric iron oxide-organic acid (Fe-OA)||Early Phase 1|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||A Pilot Study to Assess the Influence of Dietary Organic Acids on Iron Absorption.|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
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.
Dietary Supplement: ferrous sulphate
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.
Dietary Supplement: ferric iron oxide-organic acid (Fe-OA)
- Iron Bioavailability [ Time Frame: 14 days ]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).
- Iron absorption [ Time Frame: 4 hours ]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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991600
|MRC Human Nutrition Research|
|Cambridge, Cambridgeshire, United Kingdom, CB1 9NL|
|Study Chair:||Jonathan Powell, PhD||Medical Research Council|