NCT03228173

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

1 month

First QC Date

July 20, 2017

Last Update Submit

August 2, 2017

Conditions

Iron-deficiencyIron Deficiency AnemiaIron Deficiency (Without Anemia)

Keywords

CognitionExecutive functioningDepressionAffectadult females

Outcome Measures

Primary Outcomes (1)

  • iron deficiency symptoms

    Baseline

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPre-menopausal females
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • non-pregnant
  • female
  • years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota - Department of Food Science and Nutrition

Saint Paul, Minnesota, 55108, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum from each subject was coded and frozen in a -80 degrees C in a lab at the University of Minnesota

MeSH Terms

Conditions

Anemia, Iron-DeficiencyIron DeficienciesDepression

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavioral SymptomsBehavior

Study Officials

  • Daniel Gallaher, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2017

First Posted

July 24, 2017

Study Start

August 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

August 3, 2017

Record last verified: 2017-08

Locations

US(1)