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NCT03562143 · ClinicalTrials.gov registry record · NA

Daily vs Alternate Day Iron Supplementation for Pregnant Women With Iron Deficiency Anemia

A NA study of Iron Deficiency Anemia, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
NA
Development phase
88
Enrollment target
1
Study location

NCT03562143: Completed NA study of Iron Deficiency Anemia, sponsored by Icahn School of Medicine at Mount Sinai.

NCT03562143 is a NA study of Iron Deficiency Anemia that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 88 participants, below the 190-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03562143, a NA study of Iron Deficiency Anemia, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
NA
Development phase
88 participants
Enrollment target
1
Study location

Study Summary

Iron deficiency is thought to be the most common nutrient deficiency among pregnant women and the most common cause of anemia in pregnancy. The consequences of iron deficiency anemia are serious and can include diminished intellectual and productive capacity and possibly increased susceptibility to infection in mothers and infants, low birthweight, and premature births, hence the importance of appropriate treatment during pregnancy. Most guidelines recommend an increase in iron consumption by about 15-30 mg/day, an amount readily met by most prenatal vitamin formulations. This is adequate supplementation for non-anemic and non-iron-deficient women. However, women with iron deficiency anemia should receive an additional 30-20 mg/day until the anemia is corrected. It is not clear whether intermittent administration of oral iron is equivalent to once daily to rise the hemoglobin levels in pregnant women with iron deficiency anemia. Alternate day treatment with supplemental iron has been suggested as a way to improve its absorption because daily doses may suppress the mucosal uptake of iron even in the presence of iron deficiency until the intestinal mucosa completes its turnover. Another possible factor associated with the frequency of iron dosing is related to hepcidin, the central regulatory molecule in the metabolism of iron in mammals. The synthesis of hepcidin is controlled by 3 kinds of signals: inflammation; the need for increased erythropoiesis, and an iron status signal based on plasma iron levels and iron stores. If plasma iron levels or iron stores are increased, the resulting signal increases hepcidin levels, thereby blocking iron absorption and its release from stores (liver, macrophages) and preventing iron overload.This hepcidin effect, suppressing iron absorption, could last as long as 48h. In this study, the researchers aim to determine if alternate day dosing of iron in pregnant women with iron deficiency anemia results in improved levels of hemog

Primary Outcome

The change in the level of hemoglobin in pregnant patients with iron deficiency anemia after 6 weeks of treatment with either daily or alternate-day iron supplementation.

Conditions Studied

Interventions

  • DIETARY_SUPPLEMENT Ferrous Sulfate

Study Locations (1)

New York

  • Mount Sinai West - New York

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2018-08-31
Est. Completion 2020-02-20
Phase NA

What the finished NCT03562143 record still lists

NCT03562143 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 190-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (54% lower).

The record links to 1 condition, with Iron Deficiency Anemia appearing as the primary indexed condition, and to 1 intervention - of which Ferrous Sulfate is the first listed.

NCT03562143 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT03562143 about?

NCT03562143 is a clinical study titled "Daily vs Alternate Day Iron Supplementation for Pregnant Women With Iron Deficiency Anemia". Iron deficiency is thought to be the most common nutrient deficiency among pregnant women and the most common cause of anemia in pregnancy. The consequences of iron deficiency anemia are serious and can include diminished intellectual and productive capacity and possibly increased susceptibility to ...

What is the current status of trial NCT03562143?

This trial is currently completed. It is a NA study. The enrollment target is 88 participants. The study started on 2018-08-31. Estimated completion is 2020-02-20.

What conditions does trial NCT03562143 study?

This clinical trial studies the following conditions: Iron Deficiency Anemia.

What interventions are being tested in trial NCT03562143?

The interventions under investigation include: Ferrous Sulfate (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT03562143?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03562143 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Iron Deficiency Anemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03562143's enrollment target sits among peer trials

88 12th of 24 higher than 13 of 24 other Iron Deficiency Anemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Iron Deficiency Anemia 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 NCT03562143, the US trial registry maintained by the National Library of Medicine. NCT03562143 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.