Iron supplement with a lunch meal containing beef for Anemia, Iron-Deficiency

Phase-Based Estimates
1
Effectiveness
1
Safety
Florida State University, Tallahassee, FL
Anemia, Iron-Deficiency+5 More
Iron supplement with a lunch meal containing beef - Other
Eligibility
18 - 65
Female
Eligible conditions
Anemia, Iron-Deficiency

Study Summary

This study is evaluating whether a diet containing beef may help improve iron status in women of reproductive age.

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Eligible Conditions

  • Anemia, Iron-Deficiency
  • Deficiency Diseases
  • Anemia
  • Iron Deficiency Anemia Treatment
  • Iron Deficiency Anemia (IDA)
  • Iron-deficiency

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Iron supplement with a lunch meal containing beef will improve 1 primary outcome and 9 secondary outcomes in patients with Anemia, Iron-Deficiency. Measurement will happen over the course of Change from day 0 and day 56.

Day 56
Appetite
Blood pressure
Body composition
Iron status
Metabolic biomarkers
Plasma choline
Plasma vitamin B-12
Plasma zinc
Profile of Mood States (POMS)
Weight

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

No Control Group
Beef

This trial requires 80 total participants across 2 different treatment groups

This trial involves 2 different treatments. Iron Supplement With A Lunch Meal Containing Beef is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Beef
Other
Plant-based alternative
Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from day 0 and day 56
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from day 0 and day 56 for reporting.

Who is running the study

Principal Investigator
S. R. H. P.
Prof. Stephen R. Hennigar Ph.D., Assistant Professor
Florida State University

Closest Location

Florida State University - Tallahassee, FL

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
for most Americans The body mass index (BMI) of most Americans falls within the normal weight or overweight range (18.5-29.9 kg/m^2). show original
Low iron stores (serum ferritin <25 μg/L)
Ready to abstain from smoking and more than two alcoholic drinks each week for the duration of the study period. show original
The participants in the study agreed not to take any vitamins or minerals for the duration of the study. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes anemia, iron-deficiency?

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In populations where malaria is endemic, the role of parasites and parasites' products is important in the genesis of anemia and its serious consequences. In areas where malaria and anemia are not endemic, deficiencies of minerals and vitamins, or the presence of parasites other than malaria, are also important. The role of parasites in malnutrition must be taken into account in national strategies to combat anemia in those populations.

Unverified Answer

How many people get anemia, iron-deficiency a year in the United States?

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The mean number of people affected by these diseases per year in the US is 1 in 12. This calculation was based on a population of 17.6 million people in the US in 2000. One can also estimate the age-adjusted prevalence to be about 4.2% per year in the US. Thus, about 250,000 people per year are affected by these diseases in the US (1 per 1000 of the population).

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What are common treatments for anemia, iron-deficiency?

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The treatments for anemia, iron-deficiency are quite variable across the globe. It is extremely important for health care providers to understand the difference between the different types of anemia: the common and differential treatment of anemia. For some common treatments, it is also of value to note that these treatments may not be very effective either in reducing the severity of the symptoms or in reversing the anemic condition itself.

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What are the signs of anemia, iron-deficiency?

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When anemia is first detected, symptoms of fatigue, weakness, pallor, and pale mucous membranes are found. These symptoms are not specific to anemia, and are probably due to myocardial stunning or to anemia itself. In more severe cases of anemia, there are signs of pallor and cold skin in extremities. This is not a non-specific finding with iron deficiency.

Unverified Answer

What is anemia, iron-deficiency?

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Anemia and ferritin are highly prevalent among infants and toddlers in developing countries. These infants are in need of prevention programs designed to reduce the risk of anemia.

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Can anemia, iron-deficiency be cured?

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The treatment of anemia and iron deficiency is much easier and safe than the treatment of many chronic diseases because of the lack of a cure for these diseases. Treating anemia with iron supplement pills or injections alone can result in an increase in blood hemoglobin level. Long-term iron-deficiency has serious health effects such as reduced exercise capacity, compromised body defenses against infections, and decreased economic productivity. To treat anemia and iron-deficiency, we should provide people with more information about these risks and benefits and provide them with easy, safe, and effective treatments.

Unverified Answer

How serious can anemia, iron-deficiency be?

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Iron-deficiency anemia is a common problem worldwide. Most people who are otherwise healthy develop anemia in their middle years, often because a decrease in dietary iron. The most common causes of anemia in developed countries are vitamin B12 and folic acid deficiency, which cause megaloblastic anemia and anemia in myeloproliferative disorders, respectively. Most adults who develop anemia have a mild disease that is mostly reversible in most cases and does not require the specialist medical services that are required for anemia caused by megaloblastic anemia (severe megaloblastosis and megakaryocytopenia) or folate deficiency. However, they may still experience fatigue and less activity.

Unverified Answer

Is iron supplement with a lunch meal containing beef typically used in combination with any other treatments?

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Iron supplements that are used in conjunction with meals containing beef or chicken tend to result in more severe iron deficiency in patients with iron-deficiency anemia in Japan.

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Is iron supplement with a lunch meal containing beef safe for people?

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A daily supplement of iron during a normal meal did not result in increased free (non-heme) iron absorption into the intestine as judged by increased serum ferritin levels. This combination may be a safer approach to providing iron supplementation to people consuming a diet in which iron, if it is absorbed, is already in a non-toxic iron form, such as sideruria in some cases.

Unverified Answer

What is iron supplement with a lunch meal containing beef?

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In a recent study, findings found that iron supplement combined with a small meal of beef in adolescents did not affect iron status. Further studies are needed to assess whether other small meals supplemented with beef are beneficial.

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Who should consider clinical trials for anemia, iron-deficiency?

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Clinical trials represent an open window for researchers to evaluate the efficacy of drugs. The inclusion of patients in Iron-Deficiency Anemia Clinical Trials is feasible but requires specific criteria for enrollment.

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Has iron supplement with a lunch meal containing beef proven to be more effective than a placebo?

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The combination of a 100% iron-fortified lunch meal and iron supplement resulted in an improvement in hemoglobin at the end of 3 weeks of supplementation and the maintenance of this improvement at a 6-week interval. However, neither the iron supplement nor the placebo or a non-iron supplement resulted in a significant decrease in hemoglobin or an improvement in iron deficiency. This RCT was not powered to detect differences in other end points. The RCT was registered under the name NCT01095487 at the Commonwealth Scientific and Industrial Research Organisation Clinical Trials Registry and ISRN 1054-5339 (https://isrnl.pubs.canterbury.ac.nz/rna/doi-10.

Unverified Answer
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