Ferrous Sulfate for Chronic Kidney Disease

Phase-Based Progress Estimates
Children's Hospital of Philadelphia, Philadelphia, PAChronic Kidney Disease+1 MoreFerrous Sulfate - Drug
1 - 21
All Sexes
What conditions do you have?

Study Summary

This trial will test whether oral iron therapy can improve muscle strength, physical activity, and eating behavior in children with CKD and mild anemia.

Eligible Conditions
  • Chronic Kidney Disease

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 0 and 3 months

0 and 3 months
Change in eating behavior
Muscle Tissue
Change in quality of life: PROMIS
Change in sedentary time
Change in the percent of skeletal muscle mass
Change in the percentage of transferrin saturation in the participants' blood

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

8%Oedema peripheral
5%Hypertension NOS
5%Diarrhea NOS
4%Oedema NOS
3%Vomiting NOS
2%Fecal Occult Blood Positive
2%Hypotension NOS
1%Fluid Overload
1%Angina pectoris
1%Flank pain
1%Lobar pneumonia NOS
1%Intraoperative haemorrhage
1%Sepsis NOS
1%Renal failure acute
1%Urinary Tract Infection NOS
1%Respiratory failure
1%Pleural effusion
1%Mental status changes
This histogram enumerates side effects from a completed 2004 Phase 3 trial (NCT00236977) in the Venofer ARM group. Side effects include: Dysgeusia with 8%, Oedema peripheral with 8%, Nausea with 5%, Constipation with 5%, Hypertension NOS with 5%.

Trial Design

2 Treatment Groups

No oral iron therapy
1 of 2
Oral Iron therapy
1 of 2

Active Control

Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Ferrous Sulfate · No Placebo Group · Phase 4

Oral Iron therapy
Experimental Group · 1 Intervention: Ferrous Sulfate · Intervention Types: Drug
No oral iron therapyNoIntervention Group · 1 Intervention: No oral iron therapy · Intervention Types:
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferrous sulfate anhydrous
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 0 and 3 months

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
997 Previous Clinical Trials
1,331,131 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
661 Previous Clinical Trials
7,855,426 Total Patients Enrolled
Oleh Akchurin, M.D.Principal InvestigatorWeill Cornell College of Medicine

Eligibility Criteria

Age 1 - 21 · All Participants · 5 Total Inclusion Criteria

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Frequently Asked Questions

Is there any hazard associated with Ferrous Sulfate intake?

"Ferrous Sulfate has reached the apex of safety assessment, scoring a 3 on our rating scale due to its Phase 4 trial status. This implies that this medication is officially approved by health regulators." - Anonymous Online Contributor

Unverified Answer

Could you provide an overview of prior studies conducted with Ferrous Sulfate?

"As of now, 78 active investigations into Ferrous Sulfate are underway with 35 in Phase 3. Most experiments on the medicine take place at a medical centre located in Sioux Falls, South Dakota; however, there is an extensive network of 9903 sites conducting clinical research concerning this drug." - Anonymous Online Contributor

Unverified Answer

How many participants are being enrolled in this research endeavor?

"Indeed, clinicaltrials.gov indicates that the research is actively recruiting participants since it was first posted on April 19th 2019 and edited most recently on October 18th 2022. The team needs to find 60 individuals from two medical facilities." - Anonymous Online Contributor

Unverified Answer

What objectives are researchers aiming to achieve with this experiment?

"The major outcome of this medical study, which will be observed during a 0 and 3 months duration, is the variance in transferrin saturation levels. Secondary indicators include fluctuation in skeletal muscle mass (calculated via bio-electrical impedance analysis), quality of life metrics as determined by PROMIS - an NIH developed tool that uses T-score to assess fatigue and physical activity - as well as changes in eating habits assessed with CEBQ questionnaires composed of 35 items." - Anonymous Online Contributor

Unverified Answer

What medical applications does Ferrous Sulfate typically fulfill?

"Ferrous Sulfate is a viable therapy for individuals suffering from folic acid deficiency, hypochromic anemia, and lactating women." - Anonymous Online Contributor

Unverified Answer

Who can partake in this medical experiment?

"Candidates between the age of 1 Year and 21 with chronic kidney diseases can apply for this research study, which will enroll around 60 participants." - Anonymous Online Contributor

Unverified Answer

Are there vacancies for interested participants in this clinical research?

"Affirmative. According to clinicaltrials.gov, the trial is actively recruiting patients with an original posting date of April 19th 2019 and a most recent edit on October 18th 2022. In order to meet their goals they must find 60 individuals between two sites." - Anonymous Online Contributor

Unverified Answer

Is the enrollment age limit for this trial greater than 80 years?

"Applicants that meet the criteria for this trial must have a minimum age of 1 and not exceed 21 years old. There are 93 studies open to minors, while 593 trials target individuals over 65." - 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.