A Functional Food for the Prevention of Iron-deficiency Anemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Manchester Metropolitan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Manchester Metropolitan University
ClinicalTrials.gov Identifier:
NCT01055431
First received: January 22, 2010
Last updated: July 13, 2010
Last verified: July 2010
  Purpose

It has been estimated that 1 in 2 women expecting a baby will be diagnosed with iron deficiency. In turn iron deficiency can affect the health and wellbeing or both mother and child. Studies show that low iron stores prior to conception and low iron intakes during pregnancy may both be contributing to this problem. Although dietary supplements may be one solution, research indicates that daily compliance is low (Nguyen et al., 2008). Furthermore, prescribed iron supplements may result in uncomfortable side-effects, including constipation (Wulff & Ekstrom, 2003).

It is been observed in Ethiopia that iron deficiency anemia is lower than average; a finding that has been attributed to regular "Teff" consumption (Gies et al., 2003). Teff (Eragrostis tef) is a staple food usually consumed in the form of Enjera (flat bread prepared using a range of cereals). Research has shown that Teff is a rich source of iron that is easily absorbed by the body.

Although it is believed that regular Teff consumption may prevent to onset of iron deficiency anemia there is no research to support this. Therefore, the aim of the present study is to es-tablish whether incorporating Teff into the daily diet may be one way to improve blood profile and prevent the onset of iron deficiency anemia in expectant mothers. Study findings will demonstrate whether Teff may be an alternative source of iron that can be easily incorporated into the daily diet of both pregnant mothers and the lay public.


Condition Intervention Phase
Anemia
Other: Control bread
Other: Teff Bread
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Teff (Eragrostis Tef) as a Functional Food for the Prevention of Pregnancy Iron-deficiency Anemia

Resource links provided by NLM:


Further study details as provided by Manchester Metropolitan University:

Primary Outcome Measures:
  • To develop Teff bread that is rich in iron (per slice). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To establish whether iron from Teff is bioavailable. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To conclude whether daily Teff consumption prevents iron-deficiency anemia in pregnancy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To use a range of different biomarkers to determine iron status. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To compare dietary intakes of iron and iron status between the Teff/control group. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: October 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Control bread
Other: Control bread
Control bread
Other Name: Low-iron bread
Active Comparator: Teff bread
Teff bread
Other: Teff Bread
Teff bread
Other Name: High-iron bread

Detailed Description:

Rationale Iron deficiency anemia is considered to be one of the most prevalent forms of malnutrition in Europe (Stoltzfus, 2003 & Hercberg et al., 2001). Pregnant mothers are particularly susceptible to the onset of iron deficiency anemia (Daily & Wylie, 2008). It has been estimated that 1 in 2 pregnant women will be diagnosed with iron deficiency (Scholl, 2005). During pregnancy maternal plasma volume expands, increasing iron requirements (Scholl et al., 2000) whilst dietary intakes generally remain unchanged (Milman, 2006). Physiologically, intestinal iron absorption may increase during pregnancy but only after iron depletion has already commenced (Milman, 2006). Research strongly suggests that pregnant women are not meeting dietary guidelines for iron (Derbyshire et al., 2009).

A Sheffield (UK) study has reported that pregnant women consume around 10.2mg of iron per day (Mouratidou et al., 2006). Another investigation undertaken in a London population found that expectant mothers had a mean intake of 10.7mg iron per day (Rees et al., 2005). A further study investigating the diet of educated, Caucasian pregnant mothers reported similar figures (Derbyshire et al., 2006). Diets deficient in iron during gestation may subsequently affect infant health, in both the short and longer term (Scholl & Reilly, 2000). Iron deficiencies in pregnancy have been linked to preterm deliveries, reduced infant birth weight, length and iron stores (Daily & Wylie, 2008). Low iron stores during periods of infant brain growth may permanently impede cognitive development (Lozoff, 2007 & Lozoff & Georgieff, 2006).

Teff (Eragrostis tef) is a staple food consumed in northern, western and central Ethiopia; usually in the form of Enjera (flat bread prepared using a range of cereals, including Eragrostis tef) (Umeta et al., 2005). Research has shown that Teff is a rich source of bioavailable iron which may be attributed to its low phytate content. Bread made with Tef enjera contains around 30mg of iron per 100g and up to 35mg when the food is fermented (Umeta et al., 2005). The iron content dramatically exceeds that of common Western foods (Corn flakes 7.9mg, boiled brown rice, 0.5mg and brown bread, 2.2mg, all per 100g consumed) (FSA, 2006). Furthermore, studies have shown that the prevalence of pregnancy iron deficiency anemia is relatively low in Ethiopia (Gies et al., 2003) which may be attributed to Eragrostis tef forming a staple part of the diet (Haidar et al., 1999).

Incorporation of Teff into the daily diet of expectant mothers may help to reduce the incidence of iron-deficiency anemia. Research shows that women do not adhere to taking large tablet supplements (Nguyen et al., 2008). Teff may therefore provide an alternative source of dietary iron that can be easily incorporated into the daily diet of both pregnant mothers and the lay public.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Caucasian
  • Primiparous
  • Singleton pregnancy (wk 20 to wk 30)
  • Non smokers
  • Pre pregnancy BMI between 19.8 and 26
  • Healthy, free from iron metabolism disorders (pregnancy induced hypertension
  • Not taking medicines known to influence iron status
  • Not taking iron supplements (multivitamins will be accounted for)
  • Free from gastrointestinal disorders
  • No allergies

Exclusion Criteria:

  • Pregnancy haemoglobin concentrations are not within the normal range (below 70g/l or over 160g/l)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055431

Contacts
Contact: Falahat W Bokhari 0161 247 ext 2613 f.bokhari@mmu.ac.uk
Contact: Emma J Derbyshire 0161 247 ext 2483 e.derbyshire@mmu.ac.uk

Locations
United Kingdom
Manchester Food Research Centre, Manchester Metropolitan University Recruiting
Manchester, United Kingdom, M14 6HR
Contact: Falahat W Bokhari    0161 247 ext 2613    f.bokhari@mmu.ac.uk   
Contact: Dr Emma J Derbyshire    0161 247 ext 2483    e.derbyshire@mmu.ac.uk   
Sponsors and Collaborators
Manchester Metropolitan University
Investigators
Principal Investigator: Dr Emma J Derbyshire Manchester Metropolitan University
  More Information

Additional Information:
Publications:
Responsible Party: Dr Emma Derbyshire, Manchester Metropolitan University
ClinicalTrials.gov Identifier: NCT01055431     History of Changes
Other Study ID Numbers: 09/H1013/69
Study First Received: January 22, 2010
Last Updated: July 13, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Manchester Metropolitan University:
iron
bioavailability
status
deficiency
anaemia
functional foods
child bearing

Additional relevant MeSH terms:
Anemia
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014