Relative Bioavailability of Ferric Pyrophosphate From an Apple Juice Drink

Iron Deficiency Clinical Trial

Official title:

Relative Bioavailability of Ferric Pyrophosphate From an Apple Juice Drink

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474682
• Other study ID #: IFR04/2006
• Status: Completed
• Phase: N/A
• First received: May 16, 2007
• Last updated: December 2, 2008

Study information

• Verified date: May 2007
• Source: Institute of Food Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to find out how well iron is absorbed when a newly developed form of ferric pyrophosphate is added to a commercial apple juice drink.

Description:

Micronized dispersible ferric pyrophosphate (MDFP) is an iron compound that has been reported to be highly bioavailable and likely to cause few sensory problems when added to food. It is therefore a potentially effective iron additive for the food industry and is particularly formulated for adding to liquids. A randomized cross−over trial will be undertaken to compare the absorption of iron added to a commercial apple juice drink as MDFP with iron added as ferrous sulphate. The null hypothesis is that absorption of iron added as MDFP is not different to absorption from iron added as ferrous sulphate.

The study population will consist of 16 women (age 18−65) with iron stores at the lower end of the normal range. This group will efficiently absorb bioavailable iron and will be sensitive to differences in bioavailability between different forms of iron. Test drinks containing added iron, labelled with stable isotopes of iron (Fe−57 or Fe−58), will be consumed on two consecutive days. Iron absorption from the drinks will be determined using the erythrocyte incorporation technique. A baseline blood sample will be taken prior to consuming the test drinks and then a second blood sample will be taken 14 days after the last test drink. Iron absorption will be calculated from the isotopic enrichment of the final blood sample, assuming that 80% of absorbed iron is incorporated into red blood cells. The order in which the volunteers will be given the MDFP or ferrous sulphate will be randomised.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Women

• Age >18 and <65

• BMI >18.5 and <35

• Serum ferritin value of =12µg/L and =50µg/L

Exclusion Criteria:

• Men

• Age < 18 or >65

• BMI <18.5 or >35

• Serum ferritin value of <12µg/L or >50µg/L

• Volunteers will be excluded if they are found to have depressed or elevated blood pressure measurements (<90/50 or<95/50 if symptomatic or >160/100)

• Diagnosed with a long-term illness requiring active treatment, e.g. diabetes, cancer, cardiovascular disease

• Gastrointestinal disease (excluding hiatus hernia unless symptomatic)

• Regular prescribed medication that may interfere with iron metabolism

• Regular use of antacids and laxatives (at least once a week)

• Women who are pregnant or less than 12 months since giving birth

• Women breast feeding

• Vitamin supplements with or without minerals if taken more than once a week, and unwillingness to discontinue occasional use for the duration of study

• Unwillingness to discontinue use of herbal supplements for the duration of study

• Use of antibiotics within four weeks prior to study start

• Parallel participation in another study which involves dietary interventions or sampling of blood that may increase the volume taken above 500ml in a 4-month period.

• Asthma requiring treatment within the last two years

• Results of clinical screening which indicate, or are judged by the HNU Medical advisor to be indicative of a health problem which could compromise the well-being of the volunteer if they participated or which would affect the study data.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Drug:
• Micronized dispersible ferric pyrophosphate

Locations

Country	Name	City	State
United Kingdom	Institute of Food Research	Norwich	Norfolk

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Food Research	The Coca-Cola Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative bioavailability of Micronized dispersible ferric pyrophosphate added to apple juice		18 months