Iron-deficiencyNCT04079322
Iron Absorption and Exercise
A study testing Meal in people with Iron-deficiency and Iron Deficiency Anemia, run by Florida State University at 1 site in United States.
Trial summary
Iron is a nutritionally essential mineral required for optimal physical and cognitive performance. Endurance exercise often leads to declines in iron status; however, the reason for the decline is not known. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Iron Deficiency Anemia
- What is being tested?
- Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2019to 4 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Members of the Florida State University Cross Country team
- Refrain from using any pain-relievers (e.g., acetaminophen, nonsteroidal anti-inflammatory drugs such as aspirin, Advil®, Aleve®, Naprosyn®), or any other aspirin-containing product on the 2 study days
- Refrain from using vitamin or mineral supplements on the study days
Who cannot join
- Musculoskeletal injury that compromise the ability to exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: Fractional Iron Absorption in Response to an Acute Bout of Exercise
Iron is a nutritionally essential mineral required for optimal physical and cognitive performance. Endurance exercise often leads to declines in iron status; however, the reason for the decline is not known. The primary objective of the proposed study is to determine the effects of an acute bout of strenuous endurance exercise on iron absorption and status and markers of inflammation in human volunteers. The investigators hypothesize that an acute bout of strenuous endurance exercise, compared to rest, will reduce iron absorption, resulting in diminished iron status, and that reduced iron absorption will be negatively associated with markers of inflammation. A secondary objective is to monitor iron status throughout a season of competition.
- Conditions
- Iron-deficiency, Iron Deficiency Anemia
- Being tested
- Meal
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MealOther
Participants will consume a meal containing a stable iron isotope following exercise or rest.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | During the exercise arm, volunteers will complete a planned workout, as prescribed by the coach. The workout will be designed to be strenuous and induce an inflammatory response. Receives: Other: Meal |
| Rest | Experimental | The rest arm will be coordinated with a planned non-workout day, as prescribed by the coach, where volunteers are either scheduled to not run or go for an easy recovery run (<6 miles at a self-described "easy" pace) later in the afternoon. Receives: Other: Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fractional iron absorption
Stable iron isotopes
Measured: Red blood cells collected on day 0 and day 14
Secondary outcomes (6)
Change in concentration of ferritin in ng/mL
Blood measure
Measured: Day 0 and day 14
Change in concentration of soluble transferrin receptor in nmol/L
Blood measure
Measured: Day 0 and day 14
Change in concentration of hemoglobin in g/L
Blood measure
Measured: Day 0 and day 14
Change in concentration of hematocrit as %
Blood measure
Measured: Day 0 and day 14
Change in concentration of hepcidin in ng/mL
Blood measure
Measured: Day 0 and day 14
Change in concentration of IL-6 in pg/mL
Blood measure
Measured: Day 0 and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start22 Aug 2019
- Primary completion4 Dec 2019
- Study completion4 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Iron-deficiencyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen R. Hennigar, Ph.D., Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079322
- Sponsor's protocol ID
- 2019.28633
- Other IDs
- 2019
- Status last verified
- Feb 2020
- First submitted
- 12 Aug 2019
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barney DE Jr, Cheung SN, Harris AR, Berryman CE, Hennigar SR. Dietary Intake and Diet Quality of Female and Male NCAA Division I Cross Country Runners from a Single University. Curr Dev Nutr. 2024 Oct 15;8(11):104475. doi: 10.1016/j.cdnut.2024.104475. eCollection 2024 Nov.
PubMed 39610765Barney DE, Ippolito JR, Berryman CE, Hennigar SR. A Prolonged Bout of Running Increases Hepcidin and Decreases Dietary Iron Absorption in Trained Female and Male Runners. J Nutr. 2022 Sep 6;152(9):2039-2047. doi: 10.1093/jn/nxac129.
PubMed 35661896
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Iron Absorption in Response to an Acute Bout of Exercise
- ClinicalTrials.gov ID
- NCT04079322
- Acronym / sponsor ID
- 2019.28633
- Conditions
- Iron-deficiency, Iron Deficiency Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Iron is a nutritionally essential mineral required for optimal physical and cognitive performance. Endurance exercise often leads to declines in iron status; however, the reason for the decline is not known. The primary objective of the proposed study is to determine the effects of an acute bout of strenuous endurance exercise on iron absorption and status and markers of inflammation in human volunteers. The investigators hypothesize that an acute bout of strenuous endurance exercise, compared to rest, will reduce iron absorption, resulting in diminished iron status, and that reduced iron absorption will be negatively associated with markers of inflammation. A secondary objective is to monitor iron status throughout a season of competition.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: MealDuring the exercise arm, volunteers will complete a planned workout, as prescribed by the coach. The workout will be designed to be strenuous and induce an inflammatory response. |
| Rest | Experimental | Other: MealThe rest arm will be coordinated with a planned non-workout day, as prescribed by the coach, where volunteers are either scheduled to not run or go for an easy recovery run (<6 miles at a self-described "easy" pace) later in the afternoon. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Members of the Florida State University Cross Country team
- Refrain from using any pain-relievers (e.g., acetaminophen, nonsteroidal anti-inflammatory drugs such as aspirin, Advil®, Aleve®, Naprosyn®), or any other aspirin-containing product on the 2 study days
- Refrain from using vitamin or mineral supplements on the study days
Key exclusion criteria (1 listed)
- Musculoskeletal injury that compromise the ability to exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MealParticipants will consume a meal containing a stable iron isotope following exercise or rest. | Other | Exercise, Rest |
Primary outcome
Change in fractional iron absorption
Time frame: Red blood cells collected on day 0 and day 14
Stable iron isotopes
6 secondary outcomes
Change in concentration of ferritin in ng/mL
Time frame: Day 0 and day 14
Change in concentration of soluble transferrin receptor in nmol/L
Time frame: Day 0 and day 14
Change in concentration of hemoglobin in g/L
Time frame: Day 0 and day 14
Change in concentration of hematocrit as %
Time frame: Day 0 and day 14
Change in concentration of hepcidin in ng/mL
Time frame: Day 0 and day 14
Change in concentration of IL-6 in pg/mL
Time frame: Day 0 and day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Derived from this study: PubMed 39610765Barney DE Jr, Cheung SN, Harris AR, Berryman CE, Hennigar SR. Dietary Intake and Diet Quality of Female and Male NCAA Division I Cross Country Runners from a Single University. Curr Dev Nutr. 2024 Oct 15;8(11):104475. doi: 10.1016/j.cdnut.2024.104475. eCollection 2024 Nov.
- Derived from this study: PubMed 35661896Barney DE, Ippolito JR, Berryman CE, Hennigar SR. A Prolonged Bout of Running Increases Hepcidin and Decreases Dietary Iron Absorption in Trained Female and Male Runners. J Nutr. 2022 Sep 6;152(9):2039-2047. doi: 10.1093/jn/nxac129.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal in people with Iron-deficiency and Iron Deficiency Anemia, run by Florida State University 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 3 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 27 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in fractional iron absorption (time frame: Red blood cells collected on day 0 and day 14). 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 NCT04079322, which also lists 2 linked publications.
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 27 Feb 2020.