A Pilot Study to Assess the Influence of Dietary Organic Acids on Iron Absorption.

NCT01991600 | Completed Early Phase 1

• 1 other identifier: 6129
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Iron deficiency is the most common micronutrient deficiency in the world today, affecting more than 60% of the global population (www.who.int/nut/ida.htm). The two main strategies for the prevention and treatment of iron deficiency involve fortification of food with iron, or direct supplementation with iron tablets. Simple iron salts (e.g. ferrous sulphate) are well absorbed but at supplemental levels (and potentially at lower levels, as used in food fortificants) can induce free radical activity resulting in gastrointestinal side effects and systematic oxidative stress. As a result, supplementation has poor compliance and improvement in iron status is compromised. Ferric salts are less inclined to produce side effects and although they are relatively well absorbed at fortification levels in food, they are poorly absorbed at the higher supplemental doses. Because certain components of food, such as organic acids, can facilitate ferric iron absorption, we now wish to determine whether dietary organic acids may similarly enable efficient absorption of supplemental ferric iron while preventing the formation of non-transferrin-bound iron (NTBI) which is a proxy for free radical activity. Our strategy is to use an iterative process between in vitro and in vivo experimentation, aimed at identifying the best choice of organic acid and the optimal ratio of iron:organic acid. The study was a cross-over, single-dose comparison against standard-of-care therapy (namely ferrous sulphate) in mildly iron deficient anaemic women. Both the investigational products and the active comparator were administered as a single dose on 2 different occasions, i.e. the investigational products on the first study visit and the active comparator 14 days later on the second study visit.

Conditions

Iron Deficiency Anaemia

Keywords

iron absorption; bioavailability; anaemia; iron deficiency; ferrous sulphate

Outcome Measures

Primary Outcomes (1)

• Iron Bioavailability

  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).

  14 days

Secondary Outcomes (1)

• Iron absorption

  4 hours

Study Arms (2)

Ferrous Sulphate

ACTIVE COMPARATOR

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

ferric iron oxide-organic acid (Fe-OA)

EXPERIMENTAL

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)

Interventions

ferrous sulphate DIETARY_SUPPLEMENT

Ferrous Sulphate

ferric iron oxide-organic acid (Fe-OA) DIETARY_SUPPLEMENT

ferric iron oxide-organic acid (Fe-OA)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Research Council: lead

Study Sites (1)

MRC Human Nutrition Research

Cambridge, Cambridgeshire, CB1 9NL, United Kingdom

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia; Iron Deficiencies

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jonathan Powell, PhD

  Medical Research Council

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 25, 2013
• Study Start: May 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

GB (1)