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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.

Completed

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

Official record
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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
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

Other trials in United States

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.

  1. 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.

  1. First posted24 Jul 2017
  2. Study startAug 2016
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

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)
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

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.

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