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NCT03212677 · ClinicalTrials.gov registry record · NA

Safe and Effective Delivery of Supplemental Iron to Healthy Volunteers

A NA study, sponsored by Tufts University.

Completed
Registry status
NA
Development phase
226
Enrollment target

NCT03212677 is a NA study that has completed, run by Tufts University. The registered enrollment target is 226 participants.

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The verdict

NCT03212677, a NA study, has completed, sponsored by Tufts University.

COMPLETED
Registry status
NA
Development phase
226 participants
Enrollment target

Study Summary

Iron deficiency-related anemia is the most common nutritional deficiency disorder in the world, mainly affecting children, women and older adults in underdeveloped countries. To combat iron deficiency, inorganic forms of iron (such as ferrous sulfate) are often used as an iron supplement. One big problem is that high levels of this kind of iron supplement produce negative health effects. This includes diarrhea, changes in the bacteria in the gut, as well as increased severity to malaria in young children in countries with high rates of that parasite. Most forms of iron are not well absorbed and, therefore, pass through the intestine to be eliminated in the stool. This unabsorbed iron can be used by gut bacteria, disturbing the balance of healthful and potentially harmful bacteria in the colon, which can increase inflammation in the body. In this study, the investigators are seeking to determine whether two new forms of iron cause fewer changes in the gut bacteria thus lowering inflammation while providing similar amounts of iron to the body. The findings from this research study are important because they will inform the development of safer treatments for iron deficiency.

Interventions

  • OTHER Placebo
  • DIETARY_SUPPLEMENT Ferrous sulfate
  • DIETARY_SUPPLEMENT Aspiron
  • DIETARY_SUPPLEMENT IHAT

Trial Details

FieldValue
Enrollment Target 226 participants
Start Date 2017-05-17
Est. Completion 2022-07-30
Phase NA

Sponsor

Tufts University

163 total trials

What the Registry Record Tells You About NCT03212677

The ClinicalTrials.gov registry entry for NCT03212677 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 226 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tufts University, which has 163 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT03212677 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03212677 about?

NCT03212677 is a clinical study titled "Safe and Effective Delivery of Supplemental Iron to Healthy Volunteers". Iron deficiency-related anemia is the most common nutritional deficiency disorder in the world, mainly affecting children, women and older adults in underdeveloped countries. To combat iron deficiency, inorganic forms of iron (such as ferrous sulfate) are often used as an iron supplement. One big pr...

What is the current status of trial NCT03212677?

This trial is currently completed. It is a NA study. The enrollment target is 226 participants. The study started on 2017-05-17. Estimated completion is 2022-07-30.

What interventions are being tested in trial NCT03212677?

The interventions under investigation include: Placebo (OTHER), Ferrous sulfate (DIETARY_SUPPLEMENT), Aspiron (DIETARY_SUPPLEMENT), IHAT (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT03212677?

This trial is sponsored by Tufts University, which has 163 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.