Ferrous sulfate for Anemia

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Texas Children's Pavilion for Women, Houston, TX
Anemia+7 More
Ferrous sulfate - Drug
Eligibility
< 65
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether taking iron every other day is better than taking it daily.

See full description

Eligible Conditions

  • Anemia
  • Heavy Menstrual Bleeding
  • Iron Deficiency Anemia (IDA)
  • Abnormal Uterine Bleeding

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Ferrous sulfate will improve 1 primary outcome and 3 secondary outcomes in patients with Anemia. Measurement will happen over the course of At enrollment.

Month 6
Retention as measured by visit follow-up adherence
Month 6
Adherence
At enrollment
Percentage of eligible patients enrolled.
Percentage of enrolled patients who agree to continue in the study after randomization

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Daily
1 of 2
Alternate Day
1 of 2
Active Control
Experimental Treatment

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ferrous Sulfate is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Alternate Day
Drug
Patients receive ferrous sulfate 325 mg (65 mg elemental iron) once every other morning.
Daily
Drug
Patients receive standard regimen of ferrous sulfate 325 mg (65 mg elemental iron) once every morning.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iron Dextran
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month, 3 months and 6 months after enrollment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 month, 3 months and 6 months after enrollment for reporting.

Who is running the study

Principal Investigator
J. P.
Prof. Jacquelyn Powers,, MD
Baylor College of Medicine

Closest Location

Texas Children's Pavilion for Women - Houston, TX

Eligibility Criteria

This trial is for female patients aged 65 and younger. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 9 years or greater and less than age 22 years
Heavy menstrual bleeding, defined as a Pictorial Blood Assessment Chart (PBAC) Score >100
Iron deficiency anemia, defined as both hemoglobin <12 g/dL and ferritin <15 ng/mL within 7 days of enrollment.

Patient Q&A Section

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

"The prevalence of anemia is low in the United States. However, due to many confounding factors, more studies are needed to fully define anemia prevalence and prevalence of iron deficiency." - Anonymous Online Contributor

Unverified Answer

What are the signs of anemia, iron-deficiency?

"Severe iron-deficiency can resemble and be indistinguishable from other illnesses, so a complete blood count is recommended. Mild, moderate and severe anemia can be distinguished on the basis of a blood smear with a low to moderate degree of anisoblastosis." - Anonymous Online Contributor

Unverified Answer

What is anemia, iron-deficiency?

"Anemia is a common condition that can be caused by several diseases in addition to vitamin deficiency or iron deficiency. These conditions include chronic viral, bacterial or parasitic infections, genetic defects like sickle cell disease, or some cancers. The most important way to get iron-deficiency anemia is in countries where iron deficiency is common." - Anonymous Online Contributor

Unverified Answer

Can anemia, iron-deficiency be cured?

"Iron supplementation has a beneficial effect in correcting anemia in this area. Further studies, including large case-control studies need to be performed to determine whether anemia can be cured, or if the anemia is a temporary phase of the disease." - Anonymous Online Contributor

Unverified Answer

What are common treatments for anemia, iron-deficiency?

"Many patients with anemia have a chronic underlying cause for their anemia. To prevent iron-deficiency anemia, most often vitamin B-12 deficiency and iron deficiency anemia in old people should be treated. Treatments for both are usually required. Treatments for anemia, such as iron, can replace lost B-12 vitamin and iron from the body to keep a person healthy. Vitamin C deficiency can lead to scurvy and must be treated with supplementation of vitamin C." - Anonymous Online Contributor

Unverified Answer

What causes anemia, iron-deficiency?

"Iron-deficiency anemias have many causes, not only low dietary intake or blood loss (such as menstruation), but also blood loss in excess (such as childbirth/transfusion) or blood loss due to gastrointestinal disease (such as celiac disease) or gastrointestinal pathology (such as stomach lining, stomach ulcer, stomach cancer or gastric cancer) that leads to gastrointestinal bleeding." - Anonymous Online Contributor

Unverified Answer

How does ferrous sulfate work?

"Iron-initiated red blood cell formation via the iron-dependent S-transferase pathway was demonstrated in cell culture. The cellular and extracellular products of this pathway were examined." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in ferrous sulfate for therapeutic use?

"The last three years have witnessed a significant growth in the commercial activity of iron supplements as ferrous sulphate and ferrous fumarate for the treatment of anaemia." - Anonymous Online Contributor

Unverified Answer

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

"Iron supplementation can be used as a primary treatment for anemia in certain patients but the risk of adverse effects from this practice is high. The cost is also much higher than the price of ferritin or haptoglobin. Clinicians will most likely offer clinical trials to patients on ferritin or haptoglobin levels when the patient is a frail elderly woman or a young female from a developing country. Trial participants typically already have a low serum ferritin concentration and poor iron stores. For women of reproductive age, it may be prudent to consider iron supplementation before trial enrollment." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving ferrous sulfate?

"Results from a recent paper of the present review suggest that ferrous sulfate warrants more rigorous investigation for the possible treatment of iron deficiency anemia in the form of iron deficiency and iron deficiency anemia among young women who are undergoing menopause." - Anonymous Online Contributor

Unverified Answer

Has ferrous sulfate proven to be more effective than a placebo?

"When iron-deficient female adolescents and young adults received either a ferrous sulfate capsule or a placebo, both groups experienced a gain in hemoglobin levels, but the ferrous sulfate group experienced a mean increase of 1 g/dL in hemoglobin level, which was significantly more than the placebo group. The increased hemoglobin levels were maintained as long as the doses continued." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets anemia, iron-deficiency?

"There is no one standard age for anemia and iron-deficiency, which is why the age a child has the most effect on their hematemesis is what the doctor will check and treat. Since anemia in children isn't treatable (without iron treatment), doctors treat it as best as they can." - Anonymous Online Contributor

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