Healthy
Conditions
Keywords
body iron excretion, Iron isotopes
Brief 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.
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.
Interventions
None listed
Sponsors
USDA Grand Forks Human Nutrition Research Center
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Must have taken iron-55 in previous study conducted by USDA Grand Forks Human Nutrition Research Center
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Iron Excretion. | 4 years | Iron excretion calculated as body Fe (mg) times turnover rate estimated from blood activity of Fe55 |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
All enrolled participants were included
Participants by arm
| Arm | Count |
|---|---|
| Male Subjects Having Consumed Iron-55 Tracer | 38 |
| Menstruating Women Having Consumed Iron-55 Tracer Includes women on hormonal contraceptives | 30 |
| Postmenopausal Women Having Consumed Iron-55 Tracer | 9 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 9 | 11 | 4 |
Baseline characteristics
| Characteristic | Male Subjects Having Consumed Iron-55 Tracer | Menstruating Women Having Consumed Iron-55 Tracer | Postmenopausal Women Having Consumed Iron-55 Tracer | Total |
|---|---|---|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 8 | 40 years STANDARD_DEVIATION 5 | 50 years STANDARD_DEVIATION 5 | 43 years STANDARD_DEVIATION 7 |
| Sex: Female, Male Female | 0 Participants | 30 Participants | 9 Participants | 39 Participants |
| Sex: Female, Male Male | 38 Participants | 0 Participants | 0 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 19 | 0 / 5 |
| serious Total, serious adverse events | 0 / 29 | 0 / 19 | 0 / 5 |
Outcome results
Primary
Rate of Iron Excretion.
Iron excretion calculated as body Fe (mg) times turnover rate estimated from blood activity of Fe55
Time frame: 4 years
Population: Per protocol
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Male Subjects Having Consumed Iron-55 Tracer | Rate of Iron Excretion. | 1.07 milligrams per day |
| Menstruating Women Having Consumed Iron-55 Tracer | Rate of Iron Excretion. | 1.69 milligrams per day |
| Postmenopausal Women Having Consumed Iron-55 Tracer | Rate of Iron Excretion. | 1.08 milligrams per day |
p-value: <0.05ANOVA