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Iron Supplement

Oral Iron for Chronic Kidney Disease (FeTCh-CKD Trial)

Phase 4
Recruiting
Led By Oleh Akchurin, M.D.
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 1-21 years old (muscle strength will be assessed only in children >3 year old)
Children with transferrin saturation ≤ 20% AND serum ferritin ≤ 100 ng/mL will be randomized into one of the arms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 and 3 months
Awards & highlights

FeTCh-CKD Trial 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.

Who is the study for?
This trial is for children aged 1-21 with chronic kidney disease and mild anemia, not on hemodialysis or expecting a transplant soon. They must have specific levels of kidney function, hemoglobin, transferrin saturation, and serum ferritin to join.Check my eligibility
What is being tested?
The study tests if taking oral iron (ferrous sulfate) helps improve muscle strength, physical activity, and eating behavior in these kids compared to those who don't get iron therapy over a period of three months.See study design
What are the potential side effects?
Possible side effects from ferrous sulfate include stomach upset, constipation or diarrhea. These are common when starting iron supplements but often lessen over time.

FeTCh-CKD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 1 and 21 years old.
Select...
My child has low iron levels, with specific blood test results.
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My last blood test showed low hemoglobin for my age and gender.

FeTCh-CKD Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Muscle Tissue
Change in the percentage of transferrin saturation in the participants' blood
Secondary outcome measures
Change in eating behavior
Change in quality of life: PROMIS
Change in sedentary time
+1 more

Side effects data

From 2004 Phase 3 trial • 182 Patients • NCT00236977
8%
Oedema peripheral
8%
Dysgeusia
5%
Diarrhea NOS
5%
Constipation
5%
Dizziness
5%
Hypertension NOS
5%
Nausea
4%
Oedema NOS
3%
Fatigue
3%
Vomiting NOS
2%
Fecal Occult Blood Positive
2%
Hypotension NOS
1%
Renal failure acute
1%
Respiratory failure
1%
Sepsis NOS
1%
Fluid Overload
1%
Mental status changes
1%
Pleural effusion
1%
Intraoperative haemorrhage
1%
Lobar pneumonia NOS
1%
Urinary Tract Infection NOS
1%
Hyponatraemia
1%
Angina pectoris
1%
Dyspnea
1%
Flank pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Venofer
Ferrous Sulfate

FeTCh-CKD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Oral Iron therapyExperimental Treatment1 Intervention
Participant will receive oral iron therapy.
Group II: No oral iron therapyActive Control1 Intervention
Participant will not receive oral iron therapy for 3 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferrous Sulfate
2003
Completed Phase 4
~1390

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,052 Previous Clinical Trials
1,330,213 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
705 Previous Clinical Trials
8,571,333 Total Patients Enrolled
Oleh Akchurin, M.D.Principal InvestigatorWeill Cornell College of Medicine

Media Library

Ferrous Sulfate (Iron Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03991169 — Phase 4
Chronic Kidney Disease Research Study Groups: Oral Iron therapy, No oral iron therapy
Chronic Kidney Disease Clinical Trial 2023: Ferrous Sulfate Highlights & Side Effects. Trial Name: NCT03991169 — Phase 4
Ferrous Sulfate (Iron Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03991169 — Phase 4

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~8 spots leftby Dec 2024