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

March 17, 2020 updated by: Icahn School of Medicine at Mount Sinai

Daily vs Alternate Day Iron Supplementation for Pregnant Women With Iron Deficiency Anemia: A Randomized Controlled

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 hemoglobin or hematocrit and ferritin.

Hepcidin levels will be compared between patients on daily iron supplementation versus alternate day supplementation.

The researchers will also evaluate if alternate day dosing of iron supplementation results in a better side effect profile, and with better patient compliance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
        • Mount Sinai West

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant patients with iron deficiency anemia, defined as Hb less than 11.0 or hematocrit less than 33% with ferritin 25 ug/L
  • Age 18-64 years old.
  • Gestational age between 12 0/7 weeks and 34 0/7 weeks.
  • No other known causes of anemia (Folate or vit b12 deficiency anemia, sideroblastic anemia, thalassemia, sickle cell anemia, aplastic anemia, hemolytic anemia, anemia of chronic disease). Anemic patients with a low ferritin level and a mean corpuscular volume (MCV) >95 will have folate and vitamin B12 measured since some patients might have combined causes of anemia and might not respond as expected to iron supplementation only.

Patients will also be required to have a normal HB electrophoresis; this is a routine test obtained on all prenatal patients.

Exclusion Criteria:

  • Patients currently receiving iron supplementation
  • Malabsorptive and restrictive bariatric surgery
  • Inflammatory bowel disease
  • Irritable bowel syndrome
  • Celiac disease/atrophic gastritis/Helicobacter pylori
  • Active infection (ferritin can be falsely elevated since apoferritin is an acute-phase protein like CRP and increases both during infections and inflammatory reactions eg postoperatively).
  • Patients with contraindications to iron supplementation such as iron overload or hypersensitivity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alternate-day iron supplementation
Patients taking iron supplementation given as 2 tabs of 325 mg ferrous sulfate (equivalent to 130 mg of elemental iron) for 6 weeks.
Dietary supplement: Ferrous Sulfate
Patients will take iron supplementation given as 2 tabs of 325 mg ferrous sulfate (equivalent to 130 mg of elemental iron) on alternate day for 6 weeks.
Other Names:
  • Alternate-day iron supplementation
Dietary supplement: Ferrous Sulfate
Patients will take iron supplementation given as 1 tab of 325 mg ferrous sulfate (equivalent to 65 mg of elemental iron) daily for 6 weeks.
Other Names:
  • Daily iron supplementation
Active Comparator: Daily iron supplementation
Patients taking iron supplementation given as 1 tab of 325 mg ferrous sulfate (equivalent to 65 mg of elemental iron) for 6 weeks.
Dietary supplement: Ferrous Sulfate
Patients will take iron supplementation given as 2 tabs of 325 mg ferrous sulfate (equivalent to 130 mg of elemental iron) on alternate day for 6 weeks.
Other Names:
  • Alternate-day iron supplementation
Dietary supplement: Ferrous Sulfate
Patients will take iron supplementation given as 1 tab of 325 mg ferrous sulfate (equivalent to 65 mg of elemental iron) daily for 6 weeks.
Other Names:
  • Daily iron supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin Level
Time Frame: baseline and 6 weeks
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.
baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Ferritin Level
Time Frame: baseline and 6 weeks
Change in the level of ferritin in pregnant patients with iron deficiency anemia after 6 weeks of treatment with either daily or alternate-day iron supplementation.
baseline and 6 weeks
Change in Fasting Hepcidin Level
Time Frame: Baseline and Day 43 post treatment
At the end of the 6 weeks of treatment, hepcidin levels will be obtained on day 43 of the study. The 6-week hepcidin level will be compared to the starting hepcidin which will be drawn prior to initiating iron supplementation.
Baseline and Day 43 post treatment
Side effects from Iron Supplementation Questionnaire
Time Frame: 6 weeks
Patients will be asked to fill a questionnaire after 6 weeks to assess for adverse symptoms associated with consumption of iron including constipation, nausea, vomiting, diarrhea, abdominal pain, and headache. Each of these items is scaled from 0 (not al all) to 10 (very much), with total scale from 0-60, with higher score indicating more severe symptoms.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Melissa T Chu Lam, MD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2018

Primary Completion (Actual)

February 20, 2020

Study Completion (Actual)

February 20, 2020

Study Registration Dates

First Submitted

June 7, 2018

First Submitted That Met QC Criteria

June 18, 2018

First Posted (Actual)

June 19, 2018

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 18-1781

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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