CClinicalTrials.gg
CompletedNCT00755105Updated Jul 2, 2018Results posted

Measurements of Body Iron Excretion of Healthy Adults

An observational study in Healthy, sponsored by USDA Grand Forks Human Nutrition Research Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-02.

Sponsored by USDA Grand Forks Human Nutrition Research Center · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
77
Ages
18 Years and older
Sex
All
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Study summary

This is an observation study of subjects who previously had iron-55 isotope administered in studies of iron absorption. By determining the retention of the isotope in blood during a 3-year period, body iron excretion can be measured.

Read the detailed description

One year following initial administration of iron-55 as a part of other related studies, subjects provide blood samples every 6 months for 3 years.

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Conditions studied

  • Healthy

Keywords

  • body iron excretion
  • Iron isotopes
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In context

Lead sponsor

USDA Grand Forks Human Nutrition Research Center is the lead sponsor of 58 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy adult men and women who previously participated in iron absorption studies using iron-55 isotope.

Inclusion criteria

  • Must have taken iron-55 in previous study conducted by USDA Grand Forks Human Nutrition Research Center

Exclusion criteria

Exclusion Criteria:

  • None
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
77 participants (actual)
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What researchers measure

Primary outcomes

  1. Rate of Iron Excretion.

    Iron excretion calculated as body Fe (mg) times turnover rate estimated from blood activity of Fe55

    Time frame: 4 years

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Results

Posted Apr 9, 2009

Participant flow

Participants were invited to join the study if they had participated in a study involving consumption of Iron-55 at least one year earlier at Grand Forks Human Nutrition Research Center

Participant flow — Overall Study
MilestoneMale Subjects Having Consumed Iron-55 TracerMenstruating Women Having Consumed Iron-55 TracerPostmenopausal Women Having Consumed Iron-55 Tracer
Started38309
Completed29195
Not completed9114
Withdrew: Withdrawal by subject9114

Outcome measures

PrimaryRate of Iron Excretion.

Iron excretion calculated as body Fe (mg) times turnover rate estimated from blood activity of Fe55

Time frame:
4 years
Reported as:
Mean · milligrams per day
Rate of Iron Excretion.
milligrams per dayMale Subjects Having Consumed Iron-55 TracerMenstruating Women Having Consumed Iron-55 TracerPostmenopausal Women Having Consumed Iron-55 Tracer
Rate of Iron Excretion.1.07 (0.89 to 1.25)1.69 (1.30 to 2.20)1.08 (0.73 to 1.43)
Statistical analysis
  • Male Subjects Having Consumed Iron-55 Tracer vs Menstruating Women Having Consumed Iron-55 Tracer vs Postmenopausal Women Having Consumed Iron-55 Tracer · ANOVA · p = < 0.05

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Male Subjects Having Consumed Iron-55 Tracer—0/29 (0%)0/29 (0%)
Menstruating Women Having Consumed Iron-55 Tracer—0/19 (0%)0/19 (0%)
Postmenopausal Women Having Consumed Iron-55 Tracer—0/5 (0%)0/5 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Male Subjects Having Consumed Iron-55 TracerMenstruating Women Having Consumed Iron-55 TracerPostmenopausal Women Having Consumed Iron-55 TracerTotal
Mean43 ± 840 ± 550 ± 543 ± 7
Sex: Female, Male
Sex: Female, Male(Participants)Male Subjects Having Consumed Iron-55 TracerMenstruating Women Having Consumed Iron-55 TracerPostmenopausal Women Having Consumed Iron-55 TracerTotal
Female030939
Male380038
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Study locations

1 site
  • USDA Grand Forks Human Nutrition Research Center
    Grand Forks, North Dakota 58202, United States
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References and documents

Publications

  • Hunt JR, Zito CA, Johnson LK. Body iron excretion by healthy men and women. Am J Clin Nutr. 2009 Jun;89(6):1792-8. doi: 10.3945/ajcn.2009.27439. Epub 2009 Apr 22. PubMed 19386738 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00755105
Lead sponsor
USDA Grand Forks Human Nutrition Research Center
Responsible party
Sponsor
First posted
Sep 18, 2008
Start date
Sep 1998
Primary completion
Dec 2005
Completion
Dec 2005
Results posted
Apr 9, 2009
Last update
Jul 2, 2018

Study contacts

Janet R Hunt
principal investigator · USDA Grand Forks Human Nutrition Research Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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