HealthyNCT00755105

Measurements of Body Iron Excretion of Healthy Adults

An observational study of Healthy, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
How many people: 77 participants
Where: 1 siteUnited States
Study dates: Sep 1998to Dec 2005
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

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

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

United States1 site

USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58202

Other trials in United States

About this study

Official title: Body Iron Excretion of Healthy Adults as Measured by Isotope Dilution

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.

Conditions: Healthy
Keywords: body iron excretion, Iron isotopes

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Iron Excretion.
Iron excretion calculated as body Fe (mg) times turnover rate estimated from blood activity of Fe55
Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 1998Dec 2005

First posted18 Sep 2008 (estimated)
Study startSep 1998
Primary completionDec 2005
Study completionDec 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00755105
Sponsor's protocol ID: GFHNRC049
Status last verified: May 2018
First submitted: 16 Sep 2008
Last updated: 2 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Body Iron Excretion of Healthy Adults as Measured by Isotope Dilution
ClinicalTrials.gov ID: NCT00755105
Acronym / sponsor ID: GFHNRC049
Conditions: Healthy
Keywords: body iron excretion, Iron isotopes
Study type: Observational
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: USDA Grand Forks Human Nutrition Research CenterUS federal agency
Study start: Sep 1998
Primary completion: Dec 2005 (actual)
Study completion: Dec 2005 (actual)
First posted: 18 Sep 2008 (estimated)
Results: Posted 9 Apr 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Other
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Healthy adult men and women who previously participated in iron absorption studies using iron-55 isotope.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Rate of Iron Excretion.
Time frame: 4 years
Iron excretion calculated as body Fe (mg) times turnover rate estimated from blood activity of Fe55

Results and safety

Results posted to the registry on 9 Apr 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Male Subjects Having Consumed Iron-55 Tracer	38	29
Menstruating Women Having Consumed Iron-55 Tracer	30	19
Postmenopausal Women Having Consumed Iron-55 Tracer	9	5

Primary outcome: Rate of Iron Excretion.

Time frame: 4 years. Mean (95% Confidence Interval). Unit: milligrams per day

Measure	Male Subjects Having Consumed Iron-55 Tracer n = 29	Menstruating Women Having Consumed Iron-55 Tracer n = 19	Postmenopausal Women Having Consumed Iron-55 Tracer n = 5
Value	1.07 (0.89 to 1.25)	1.69 (1.30 to 2.20)	1.08 (0.73 to 1.43)

Male Subjects Having Consumed Iron-55 Tracer vs Menstruating Women Having Consumed Iron-55 Tracer vs Postmenopausal Women Having Consumed Iron-55 Tracer: p < 0.05, ANOVA

Population analysed: Per protocol

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Male Subjects Having Consumed Iron-55 Tracer	0 of 29 (0%)	0 of 29 (0%)	Not reported
Menstruating Women Having Consumed Iron-55 Tracer	0 of 19 (0%)	0 of 19 (0%)	Not reported
Postmenopausal Women Having Consumed Iron-55 Tracer	0 of 5 (0%)	0 of 5 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 19386738Hunt 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.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janet R Hunt principal investigator

USDA Grand Forks Human Nutrition Research Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Iron Excretion. (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00755105, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.