NCT00474682

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2007

Completed
Last Updated

December 3, 2008

Status Verified

May 1, 2007

First QC Date

May 16, 2007

Last Update Submit

December 2, 2008

Conditions

Iron Deficiency

Keywords

ferric pyrophosphate, iron bioavailability, fortification,

Outcome Measures

Primary Outcomes (1)

  • Relative bioavailability of Micronized dispersible ferric pyrophosphate added to apple juice

    18 months

Interventions

Micronized dispersible ferric pyrophosphateDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women
  • Age \>18 and \<65
  • BMI \>18.5 and \<35
  • Serum ferritin value of =12μg/L and =50μg/L

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Food Research

Norwich, Norfolk, NR4 6JF, United Kingdom

Location

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Susan J Fairweather-Tait

    University of East Anglia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 16, 2007

First Posted

May 17, 2007

Last Updated

December 3, 2008

Record last verified: 2007-05

Locations

GB(1)