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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 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.
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
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Ferrous Sulfate
Study Locations (1)
New York
- Mount Sinai West - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2018-08-31 |
| Est. Completion | 2020-02-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03562143
The ClinicalTrials.gov registry entry for NCT03562143 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 190-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (54% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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