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A Functional Food for the Prevention of Iron-deficiency Anemia

This study has been completed.
Sponsor:
Information provided by:
Manchester Metropolitan University
ClinicalTrials.gov Identifier:
NCT01055431
First received: January 22, 2010
Last updated: July 29, 2014
Last verified: July 2010

January 22, 2010
July 29, 2014
October 2009
July 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01055431 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Functional Food for the Prevention of Iron-deficiency Anemia
Teff (Eragrostis Tef) as a Functional Food for the Prevention of Pregnancy Iron-deficiency Anemia

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Anemia
  • Other: Control bread
    Control bread
    Other Name: Low-iron bread
  • Other: Teff Bread
    Teff bread
    Other Name: High-iron bread
  • Placebo Comparator: Control
    Control bread
    Intervention: Other: Control bread
  • Active Comparator: Teff bread
    Teff bread
    Intervention: Other: Teff Bread
McKenna D, Spence D, Haggan SE, McCrum E, Dornan JC, Lappin TR. A randomized trial investigating an iron-rich natural mineral water as a prophylaxis against iron deficiency in pregnancy. Clin Lab Haematol. 2003 Apr;25(2):99-103.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
July 2011
July 2011   (final data collection date for primary outcome measure)

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)
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01055431
09/H1013/69
Yes
Dr Emma Derbyshire, Manchester Metropolitan University
Manchester Metropolitan University
Not Provided
Principal Investigator: Dr Emma J Derbyshire Manchester Metropolitan University
Manchester Metropolitan University
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP