A Functional Food for the Prevention of Iron-deficiency Anemia

NCT01055431 | Completed Phase 1 DMC

• 1 other identifier: 09/H1013/69
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia

Keywords

iron; bioavailability; status; deficiency; anaemia; functional foods; child bearing

Outcome Measures

Primary Outcomes (3)

• To develop Teff bread that is rich in iron (per slice).

  2 years

• To establish whether iron from Teff is bioavailable.

  2 years

• To conclude whether daily Teff consumption prevents iron-deficiency anemia in pregnancy.

  2 years

Secondary Outcomes (2)

• To use a range of different biomarkers to determine iron status.

  2 years

• To compare dietary intakes of iron and iron status between the Teff/control group.

  2 years

Study Arms (2)

Control

PLACEBO COMPARATOR

Control bread

Other: Control bread

Teff bread

ACTIVE COMPARATOR

Teff bread

Other: Teff Bread

Interventions

Control bread OTHER

Control bread

Also known as: Low-iron bread

Control

Teff Bread OTHER

Teff bread

Also known as: High-iron bread

Teff bread

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy haemoglobin concentrations are not within the normal range (below 70g/l or over 160g/l)

Sponsors & Collaborators

• Manchester Metropolitan University: lead

Study Sites (1)

Manchester Food Research Centre, Manchester Metropolitan University

Manchester, M14 6HR, United Kingdom

Location

Related Publications (1)

• 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. doi: 10.1046/j.1365-2257.2003.00501.x.

  PMID: 12641613 BACKGROUND

Related Links

• Manchester Metropolitan University
• ROCHE Foundation for Anemia Research

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Dr Emma J Derbyshire

  Manchester Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 22, 2010
• First Posted: January 25, 2010
• Study Start: October 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 30, 2014

Record last verified: 2010-07

Locations

GB (1)