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Iron Supplement

Meals + Iron Supplements for Iron Deficiency

N/A
Recruiting
Led By Stephen Hennigar, Ph.D.
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
History of any disease or abnormality of the gastrointestinal tract including, but not limited to, diverticulosis, diverticulitis and inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis; or previous gastrointestinal surgery
Currently taking a medication that interferes with micronutrient metabolism
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from day 0 and day 56
Awards & highlights

Summary

This trial is looking at the effects of incorporating daily meals containing beef or plant-based alternative with or without an iron supplement on indicators of iron status in iron-deficient women of reproductive age.

Who is the study for?
This trial is for women of reproductive age with normal to slightly overweight BMI (18.5-29.9) and low iron stores who don't smoke or drink heavily. It's not for those on certain medications, with blood clotting issues, metabolic/cardiovascular abnormalities, recent blood donors, or those unwilling to stop vitamin/mineral supplements.
What is being tested?
The study tests if daily meals containing beef or a plant-based alternative affect iron status when taken with an iron supplement in women with low iron levels. The goal is to see which meal helps improve the body's absorption of non-heme iron from supplements.
What are the potential side effects?
While specific side effects are not listed, potential ones may include digestive discomfort due to dietary changes and possible reactions to the iron supplement such as constipation or stomach upset.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had issues or surgery related to my digestive system.
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I am on medication that affects how my body processes vitamins and minerals.
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I have a condition like kidney disease, diabetes, or heart disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from day 0 and day 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from day 0 and day 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Iron status
Secondary study objectives
Appetite
Blood pressure
Body composition
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Plant-based alternativeExperimental Treatment1 Intervention
Group II: BeefExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Florida State UniversityLead Sponsor
213 Previous Clinical Trials
34,416 Total Patients Enrolled
Pennington Biomedical Research CenterLead Sponsor
307 Previous Clinical Trials
181,081 Total Patients Enrolled
Stephen Hennigar, Ph.D.Principal InvestigatorFlorida State University

Media Library

Iron supplement with a lunch meal containing beef (Iron Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04793906 — N/A
Iron-Deficiency Anemia Research Study Groups: Plant-based alternative, Beef
Iron-Deficiency Anemia Clinical Trial 2023: Iron supplement with a lunch meal containing beef Highlights & Side Effects. Trial Name: NCT04793906 — N/A
Iron supplement with a lunch meal containing beef (Iron Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04793906 — N/A
~2 spots leftby Nov 2024