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Iron Supplement

Iron Supplementation for Anemia of Prematurity

Q: What clinical conditions can be improved by Low Iron Sulfate Supplementation?

Low Iron Sulfate Supplementation can be employed to ameliorate anemia, chronic kidney diseases, and iron deficiency.

Q: What other scientific studies have been conducted regarding Low Iron Sulfate Supplementation?

Currently, 84 Low Iron Sulfate Supplementation trials are on-going with 34 in their final phase. Of the 9968 locations conducting research for this intervention, a few are situated in Sioux Falls, <a href="https://www.withpower.com/clinical-trials/south-dakota">South dakota</a>.

Q: Has the administration endorsed Low Iron Sulfate Supplementation as a viable therapy?

With a score of 3, Low Iron Sulfate Supplementation is assessed to be safe as this Phase 4 trial confirms its approval.

Q: What is the current number of participants involved in this investigation?

Confirmed. Clinicaltrials.gov's records show that this clinical trial, which was initially advertised on 17th of November 2020, is actively searching for participants. The study requires 183 patients to be enlisted from a single medical institution.

Q: Are those aged 85 and below admissible for this experiment?

According to the guidelines of this experiment, enrollees must be between 1 Day and 6 Months old.

Q: For whom would this clinical trial be an optimal fit?

This medical trial is looking for 183 neonates between 24 hours old and 6 months who have a birthweight of less than 1500 grams. In addition, the infant must be expected to live more than two weeks, not yet given OIS (Oral Iron Supplementation), with parents aged 18 or older and parental consent obtained.

Q: Are there any openings for potential participants in this experiment?

Affirmative. Clinicaltrials.gov reveals that this research, which was initially posted on November 17th 2020, is currently accepting participants. Approximately 183 patients are expected to enroll from a single medical site.

Phase 4

Recruiting

Research Sponsored by University of South Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

<1500 g at birth

not yet started on oral iron supplementation (OIS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 weeks corrected gestational age

Awards & highlights

Study Summary

This trial will study the effects of different doses of iron supplementation on the intestines of premature babies.

Who is the study for?

This trial is for very low birth weight infants under 1500g who haven't started oral iron supplements, are expected to live beyond two weeks, and have parental consent. Infants with congenital intestinal defects or a history of intestinal issues before starting supplements can't join.Check my eligibility

What is being tested?

The study tests the effects of two different doses of iron sulfate (2 mg/kg/day vs. 6 mg/kg/day) on the intestinal health of very low birth weight infants, focusing on their microbiome, inflammation levels, and barrier function.See study design

What are the potential side effects?

Potential side effects may include gastrointestinal discomfort or disturbances due to iron supplementation such as constipation or diarrhea. There might also be changes in stool color.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I weighed less than 1500 grams at birth.

Select...

I have not started taking oral iron supplements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 weeks corrected gestational age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 weeks corrected gestational age

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 weeks corrected gestational age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in fecal calprotectin from before to after iron supplementation

Change in stool bacterial percentages from before to after iron supplementation

Change in urine Claudin-3 and I-FABP from before to after iron supplementation

Secondary outcome measures

Level of Iron storage

Rate of auditory myelination

Trial Design

2Treatment groups

Active Control

Group I: High Iron Sulfate SupplementationActive Control1 Intervention

Participants will be given 6 mg/kg/day total of elemental iron once a day when they are consuming 150-160 ml/kg/day of enteral feeds and are at least 14 days old. The total iron doses will be provided by fortification of feeds and liquid iron sulfate and will be weight adjusted once a week. The participants will receive the study iron dose until 36 week corrected gestational age or discharge, whichever comes first.

Group II: Low Iron Sulfate SupplementationActive Control1 Intervention

Participants will be given 2 mg/kg/day total of elemental iron once a day when they are consuming 150-160 ml/kg/day of enteral feeds and are at least 14 days old. The total iron doses will be provided by fortification of feeds and liquid iron sulfate and will be weight adjusted once a week. The participants will receive the study iron dose until 36 week corrected gestational age or discharge, whichever comes first.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,838 Previous Clinical Trials

47,851,471 Total Patients Enrolled

University of South FloridaLead Sponsor

412 Previous Clinical Trials

186,876 Total Patients Enrolled

Media Library

Iron Sulfate (Iron Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04497012 — Phase 4

Anemia of Prematurity Research Study Groups: High Iron Sulfate Supplementation, Low Iron Sulfate Supplementation

Anemia of Prematurity Clinical Trial 2023: Iron Sulfate Highlights & Side Effects. Trial Name: NCT04497012 — Phase 4

Iron Sulfate (Iron Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04497012 — Phase 4

Frequently Asked Questions

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

What clinical conditions can be improved by Low Iron Sulfate Supplementation?

"Low Iron Sulfate Supplementation can be employed to ameliorate anemia, chronic kidney diseases, and iron deficiency."

Answered by AI

What other scientific studies have been conducted regarding Low Iron Sulfate Supplementation?

"Currently, 84 Low Iron Sulfate Supplementation trials are on-going with 34 in their final phase. Of the 9968 locations conducting research for this intervention, a few are situated in Sioux Falls, South dakota."

Answered by AI

Has the administration endorsed Low Iron Sulfate Supplementation as a viable therapy?

"With a score of 3, Low Iron Sulfate Supplementation is assessed to be safe as this Phase 4 trial confirms its approval."

Answered by AI

What is the current number of participants involved in this investigation?

"Confirmed. Clinicaltrials.gov's records show that this clinical trial, which was initially advertised on 17th of November 2020, is actively searching for participants. The study requires 183 patients to be enlisted from a single medical institution."

Answered by AI

Are those aged 85 and below admissible for this experiment?

"According to the guidelines of this experiment, enrollees must be between 1 Day and 6 Months old."

Answered by AI

For whom would this clinical trial be an optimal fit?

"This medical trial is looking for 183 neonates between 24 hours old and 6 months who have a birthweight of less than 1500 grams. In addition, the infant must be expected to live more than two weeks, not yet given OIS (Oral Iron Supplementation), with parents aged 18 or older and parental consent obtained."

Answered by AI

Are there any openings for potential participants in this experiment?

"Affirmative. Clinicaltrials.gov reveals that this research, which was initially posted on November 17th 2020, is currently accepting participants. Approximately 183 patients are expected to enroll from a single medical site."

Answered by AI

Recent research and studies

Blood ReviewsJournal

Anaemia of Prematurity: Pathophysiology and Treatment

Strauss, Ronald G.. 2010. “Anaemia of Prematurity: Pathophysiology and Treatment”. Blood Reviews. Elsevier BV. doi:10.1016/j.blre.2010.08.001.

The American Journal of Clinical NutritionJournal

The Effects of Iron Fortification on the Gut Microbiota in African Children: A Randomized Controlled Trial in Côte D'ivoire

Zimmermann, Michael B, Christophe Chassard, Fabian Rohner, Eliézer K N'Goran, Charlemagne Nindjin, Alexandra Dostal, Jürg Utzinger, Hala Ghattas, Christophe Lacroix, and Richard F Hurrell. 2010. “The Effects of Iron Fortification on the Gut Microbiota in African Children: A Randomized Controlled Trial in Côte D'ivoire”. The American Journal of Clinical Nutrition. Oxford University Press (OUP). doi:10.3945/ajcn.110.004564.

The Journal of PediatricsJournal

Effects of Different Complementary Feeding Regimens on Iron Status and Enteric Microbiota in Breastfed Infants

Krebs, Nancy F., Laurie G. Sherlock, Jamie Westcott, Diana Culbertson, K. Michael Hambidge, Leah M. Feazel, Charles E. Robertson, and Daniel N. Frank. 2013. “Effects of Different Complementary Feeding Regimens on Iron Status and Enteric Microbiota in Breastfed Infants”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2013.01.024.

GutJournal