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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: Completed NA study, sponsored by Tufts University.

NCT03212677 is a NA study that has completed, run by Tufts University. The registered enrollment target is 226 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Malaria (Plasmodium falciparum) infectivity of host erythrocytes will be assessed in vitro

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
Tufts University

163 total trials

What the finished NCT03212677 record still lists

NCT03212677 is an interventional study that assigns participants to a tested intervention. The registered 226 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).

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

NCT03212677 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT03212677's enrollment target sits among peer trials

226 471st of 2000 higher than 1,529 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03212677, the US trial registry maintained by the National Library of Medicine. NCT03212677 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.