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Ferrous Fumarate and Ferric Pyrophosphate as Food Fortificants in Developing Countries

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ClinicalTrials.gov Identifier: NCT00867867
Recruitment Status : Completed
First Posted : March 24, 2009
Last Update Posted : July 16, 2013
Sponsor:
Collaborators:
Nutrition Third World, Belgium
Nestlé Foundation
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary:

Iron fortification of foods is usually considered the most cost-effective approach to prevent iron deficiency. However, iron is the most difficult mineral to add to foods. When added as water-soluble, highly bioavailable compounds such as ferrous sulfate, the soluble iron rapidly catalyzes fat oxidation resulting in rancid products. In addition, water-soluble iron compounds can cause unacceptable color reactions during storage and food preparation. Thus, food manufacturers are often obliged to use water-insoluble iron compounds to fortify foods and fortification compounds such as elemental Fe powder and ferric pyrophosphate are widely used to fortify cereal flours and infant cereals. However, these compounds never dissolve completely in the gastric juice and are usually far less well absorbed than ferrous sulfate (Hurrell 1997). Ferrous fumarate on the other hand, although almost insoluble in water, readily dissolves in the gastric juice and has been shown to have an equivalent absorption to ferrous sulfate in healthy, Western adults (Hurrell et al. 1989, 2000). Because it is non-water soluble, it causes relatively few sensory problems in the fortified foods and is therefore an interesting food fortificant. Iron absorption from ferrous fumarate has been demonstrated to be significantly higher than from ferric pyrophosphate in European infants (Davidsson et al. 2000) and this compound is currently used to fortify blended cereal flours for food aid programs and commercial infant cereals in Europe. However, based on our recent study in Bangladeshi children, there is now concern that due to lower gastric acid output, young children in developing countries may not be able to absorb ferrous fumarate as well as Western adults (Davidsson et al. 2001a, Sarker et al. 2001, 2003). Clearly, there is a need to evaluate the efficacy of water insoluble iron compounds to prevent the development of iron deficiency/iron deficiency anemia in infants and young children living in developing countries. The aim of this study is to evaluate the efficacy of ferrous fumarate and ferric pyrophosphate, as compared to ferrous sulfate, as food fortificants in preventing development of anemia/IDA in Bangladeshi infants and young children (part I).

A potential cause of low gastric acid secretion in Bangladesh and many developing countries is Helicobacter pylori infection. Although H. pylori-infection appeared to have no influence on absorption of ferrous fumarate in children, the impact of chronic H. pylori infection in adults could be expected to be more pronounced due to long time effects on the gastric mucosa, resulting in reduced gastric acid output. The other aim of the study is therefore, to assess of iron absorption and gastric acid output in adult women of child-bearing age with H. pylori infection (part II).

Two hundred and forty non-anemic Children (Hb>105 g/L) will be randomized to three study groups; ferrous fumarate, ferric pyrophosphate or ferrous sulfate (n=80 per group) in wheat flour- and cow milk-based infant formula and will be fed for 9 months. Hemoglobin, serum ferritin, and transferin receptor will be analyzed at baseline and after 4.5 and 9 months of intervention. Prevalence of anemia and iron deficiency during and after the intervention among the three groups will be compared (part I). We furthermore propose a complementary study to determine the relative absorption of ferrous fumarate (relative to ferrous sulfate) in H. pylori infected and non-infected adult Bangladeshi women (15 each) of 20-40 year of age with IDA using stable isotope technique based on the incorporation of iron stable isotopes into erythrocytes 14 days after administration. Assessment of gastric acid output will also be performed. Iron stature and absorption, and assessment of gastric acid output will be compared before and after therapy in H. pylori infected women (part II). The results of this study are expected to have implications in the prevention and treatment of iron deficiency anemia in developing countries


Condition or disease Intervention/treatment Phase
Healthy Participants Non-anemic Children Helicobacter Pylori Infection Drug: Ferrous fumarate Drug: Ferric pyrophosphate Drug: Placebo Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Usefulness of Ferrous Fumarate and Ferric Pyrophosphate as Food Fortificants in Developing Countries
Study Start Date : October 2003
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Active Comparator: 1
Ferrous Fumarate with Ferrous Sulphate
Drug: Ferrous fumarate
9.3 mg once per day, 6 days per week, for 9 months

Active Comparator: 2
Ferric pyrophosphate with ferrous sulphate
Drug: Ferric pyrophosphate
9.3 mg once per day, 6 days per week, for 9 months

Placebo Comparator: 3
Ferrous sulphate
Drug: Placebo
9.3 mg once per day, 6 days per week, for 9 months




Primary Outcome Measures :
  1. Iron status (Haemoglobin, serum feritin, serum transferin receptor) [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Nutritional status and morbidity [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children of 9-24 months
  • Non-anaemic children (haemoglobin more than 10.5g/L)

Exclusion Criteria:

Exclusion criteria include:

  • Children with anemia (Hb<105 g/L), systemic infection or apparent inflammatory process or weight for age of < 70% of NCHS median.
  • The children with exclusion criteria will be appropriately treated or if needed, or will be referred to appropriate health center for treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00867867


Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Nutrition Third World, Belgium
Nestlé Foundation
Investigators
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Principal Investigator: Shafiqul Alam Sarker, MD, Ph.D. International Centre for Diarrhoeal Disease Research, Bangladesh

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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT00867867     History of Changes
Other Study ID Numbers: 2002-009
First Posted: March 24, 2009    Key Record Dates
Last Update Posted: July 16, 2013
Last Verified: March 2009
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Iron deficiency anemia
Helicobacter pylori
Iron absorption
Iron fortification
ferrous sulphate
ferrous fumarate
Additional relevant MeSH terms:
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Ferrous fumarate
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs