Iron-deficiencyNCT03228173
Iron Deficiency in Female State Fair Attendees
An observational study of Iron-deficiency and Iron Deficiency Anemia, run by University of Minnesota at 1 site in United States.
Trial summary
This study aims to examine iron deficiency symptoms and biochemical iron status based on hemoglobin, hematocrit, ferritin, and total iron binding capacity in menstruating females. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Iron Deficiency Anemia, Iron Deficiency (Without Anemia)
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Sep 2016
- Phase
- Observational
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Because menstruation causes much lower iron stores in adult females, this study targeted adult, menstruating, non-pregnant females. Additionally, inflammation and iron metabolism disorders can result in biochemical iron values that are difficult to interpret, so these conditions were excluded.
Who may be able to join
- non-pregnant
- female
- 18-45 years of age
Who cannot join
- pregnancy
- male
- outside age range
- post-menopausal
- experiencing one of the following inflammatory or iron metabolism disorders: active treatment for cancer, irritable bowel syndrome, colitis, Chron's disease, chronic heart failure, chronic kidney disease, chronic parasitic infection, hemochromatosis, human immunodeficiency virus, polycystic ovarian syndrome, respiratory illness, sickle cell anemia, and thalassemia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota - Department of Food Science and Nutrition
Saint Paul, Minnesota, 55108
About this study
Official title: Iron Deficiency, Depression, and Other Affective Disorders in Female State Fair Attendees
This study aims to examine iron deficiency symptoms and biochemical iron status based on hemoglobin, hematocrit, ferritin, and total iron binding capacity in menstruating females.
Read the detailed description
Iron deficiency affects nearly 2 billion people globally, and it is among the most common risk factors for disability and death. In its most extreme presentation, it results in anemia, where the RBC count of the individual is markedly low, hindering oxygen transport. Anemia has a remarkable global presence, affecting approximately one third of the world's population. Though there are multiple causes for anemia, the World Health Organization (WHO) estimates that the most common cause for anemia on the planet is iron deficiency. Although findings from the US indicate that iron deficiency is less prevalent than in many other nations, iron deficiency is still a pervasive national public health concern. A study that analyzed the National Health and Nutrition Examination Survey (NHANES) data from 2007-2010 indicated that US children 5 years of age and younger have an anemia incidence of 3.2 percent.
Incidence of depression varies based on diagnostic tools used and categories included, as well as the country, gender, age, and socioeconomic status of individuals. Globally, it is estimated that between 4 and 10 percent of people experience major depressive disorder (MDD) while between 2.5 and 5 percent experience dysthymia, a depression that involves less severe symptoms but has a chronic manifestation. On average, the first onset of depression is 20 years old, though this figure is highly variable. It has consistently been demonstrated that females experience a much higher incidence of depression than males. MDD has repeatedly been reported in females at rates 1.5 to 3 times that of males, and female dysthymia has been reported at 2 times that of males.
The current state of the literature on the connection between mental health and iron status is further muddled by subjective, self-reported assessments and a lack of randomized controlled trials, but the evidence certainly suggests an association. Affective characteristics studied in relation to iron deficiency include irritability, anger, or mood; depression, both as postpartum depression (PPD) or depression independently; and perceived QOL. Differences in assessment tools as well as length and dosage of iron treatment likely play a pivotal role in discordant results. Most studies also include fatigue as a primary outcome as it is closely tied to these affective characteristics.
The aim of this study is to further investigate iron status and iron deficiency symptoms in menstruating females. It builds on the existing research for use of cutoff values for various biochemical assessments of iron as well as for stages of deficiency in which symptoms are experienced. In addition, the association between iron status, measured either biochemically or by self-reported iron deficiency symptoms, and depression was examined.
- Keywords
- Cognition, Executive functioning, Depression, Affect, adult females
- Medical subject headings
- Anemia, Iron-Deficiency, Iron Deficiencies, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
iron deficiency symptoms
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study startAug 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hawaii
- Responsible party
- Sponsor
- Investigators
- Daniel Gallaher, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228173
- Sponsor's protocol ID
- State Fair
- Status last verified
- Aug 2017
- First submitted
- 20 Jul 2017
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Deficiency, Depression, and Other Affective Disorders in Female State Fair Attendees
- ClinicalTrials.gov ID
- NCT03228173
- Acronym / sponsor ID
- State Fair
- Keywords
- Cognition, Executive functioning, Depression, Affect, adult females
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- University of Hawaii
- Study start
- Aug 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 24 Jul 2017 (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.
This study aims to examine iron deficiency symptoms and biochemical iron status based on hemoglobin, hematocrit, ferritin, and total iron binding capacity in menstruating females.
Detailed description
Iron deficiency affects nearly 2 billion people globally, and it is among the most common risk factors for disability and death. In its most extreme presentation, it results in anemia, where the RBC count of the individual is markedly low, hindering oxygen transport. Anemia has a remarkable global presence, affecting approximately one third of the world's population. Though there are multiple causes for anemia, the World Health Organization (WHO) estimates that the most common cause for anemia on the planet is iron deficiency. Although findings from the US indicate that iron deficiency is less prevalent than in many other nations, iron deficiency is still a pervasive national public health concern. A study that analyzed the National Health and Nutrition Examination Survey (NHANES) data from 2007-2010 indicated that US children 5 years of age and younger have an anemia incidence of 3.2 percent.
Incidence of depression varies based on diagnostic tools used and categories included, as well as the country, gender, age, and socioeconomic status of individuals. Globally, it is estimated that between 4 and 10 percent of people experience major depressive disorder (MDD) while between 2.5 and 5 percent experience dysthymia, a depression that involves less severe symptoms but has a chronic manifestation. On average, the first onset of depression is 20 years old, though this figure is highly variable. It has consistently been demonstrated that females experience a much higher incidence of depression than males. MDD has repeatedly been reported in females at rates 1.5 to 3 times that of males, and female dysthymia has been reported at 2 times that of males.
The current state of the literature on the connection between mental health and iron status is further muddled by subjective, self-reported assessments and a lack of randomized controlled trials, but the evidence certainly suggests an association. Affective characteristics studied in relation to iron deficiency include irritability, anger, or mood; depression, both as postpartum depression (PPD) or depression independently; and perceived QOL. Differences in assessment tools as well as length and dosage of iron treatment likely play a pivotal role in discordant results. Most studies also include fatigue as a primary outcome as it is closely tied to these affective characteristics.
The aim of this study is to further investigate iron status and iron deficiency symptoms in menstruating females. It builds on the existing research for use of cutoff values for various biochemical assessments of iron as well as for stages of deficiency in which symptoms are experienced. In addition, the association between iron status, measured either biochemically or by self-reported iron deficiency symptoms, and depression was examined.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Because menstruation causes much lower iron stores in adult females, this study targeted adult, menstruating, non-pregnant females. Additionally, inflammation and iron metabolism disorders can result in biochemical iron values that are difficult to interpret, so these conditions were excluded.
Key inclusion criteria (3 listed)
- non-pregnant
- female
- 18-45 years of age
Key exclusion criteria (5 listed)
- pregnancy
- male
- outside age range
- post-menopausal
- experiencing one of the following inflammatory or iron metabolism disorders: active treatment for cancer, irritable bowel syndrome, colitis, Chron's disease, chronic heart failure, chronic kidney disease, chronic parasitic infection, hemochromatosis, human immunodeficiency virus, polycystic ovarian syndrome, respiratory illness, sickle cell anemia, and thalassemia
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
iron deficiency symptoms
Time frame: Baseline
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 3 Aug 2017.
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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.
Daniel Gallaher, PhD principal investigator
University of Minnesota
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 Iron-deficiency and Iron Deficiency Anemia, run by University of Minnesota 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 5 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 3 Aug 2017. 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?
iron deficiency symptoms (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2017.