Trial Outcomes & Findings for Measurements of Body Iron Excretion of Healthy Adults (NCT NCT00755105)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

77 participants

Primary outcome timeframe

4 years

Results posted on

2018-07-02

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

All enrolled participants were included

Participant milestones

Participant milestones
Measure	Male Subjects Having Consumed Iron-55 Tracer	Menstruating Women Having Consumed Iron-55 Tracer Includes women on hormonal contraceptives	Postmenopausal Women Having Consumed Iron-55 Tracer
Overall Study STARTED	38	30	9
Overall Study COMPLETED	29	19	5
Overall Study NOT COMPLETED	9	11	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Male Subjects Having Consumed Iron-55 Tracer	Menstruating Women Having Consumed Iron-55 Tracer Includes women on hormonal contraceptives	Postmenopausal Women Having Consumed Iron-55 Tracer
Overall Study Withdrawal by Subject	9	11	4

Baseline Characteristics

Measurements of Body Iron Excretion of Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Male Subjects Having Consumed Iron-55 Tracer n=38 Participants	Menstruating Women Having Consumed Iron-55 Tracer n=30 Participants Includes women on hormonal contraceptives	Postmenopausal Women Having Consumed Iron-55 Tracer n=9 Participants	Total n=77 Participants Total of all reporting groups
Age, Continuous	43 years STANDARD_DEVIATION 8 • n=5 Participants	40 years STANDARD_DEVIATION 5 • n=7 Participants	50 years STANDARD_DEVIATION 5 • n=5 Participants	43 years STANDARD_DEVIATION 7 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	30 Participants n=7 Participants	9 Participants n=5 Participants	39 Participants n=4 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	38 Participants n=4 Participants

PRIMARY outcome

Timeframe: 4 years

Population: Per protocol

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

Outcome measures

Outcome measures
Measure	Male Subjects Having Consumed Iron-55 Tracer n=29 Participants	Menstruating Women Having Consumed Iron-55 Tracer n=19 Participants Includes women on hormonal contraceptives	Postmenopausal Women Having Consumed Iron-55 Tracer n=5 Participants
Rate of Iron Excretion.	1.07 milligrams per day Interval 0.89 to 1.25	1.69 milligrams per day Interval 1.3 to 2.2	1.08 milligrams per day Interval 0.73 to 1.43

Adverse Events

Male Subjects Having Consumed Iron-55 Tracer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Menstruating Women Having Consumed Iron-55 Tracer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Postmenopausal Women Having Consumed Iron-55 Tracer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Janet Hunt, PhD

USDA Grand Forks Human Nutrition Research Center

Phone: 701-795-8353

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place