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

NCT01991600 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2013-11-25

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

ferrous sulphate

DIETARY_SUPPLEMENT

ferric iron oxide-organic acid (Fe-OA)

Sponsors & Collaborators

Principal Investigators

  • Jonathan Powell, PhD · Medical Research Council

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01991600 on ClinicalTrials.gov