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Trial record 67 of 10813 for:    Placebo AND once

Once Versus Twice Daily Iron Supplementation in Pregnant Women

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ClinicalTrials.gov Identifier: NCT02839096
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Daniel Lee Jackson, University of Missouri-Columbia

Brief Summary:
The investigators will randomize women diagnosed with anemia in the mid-trimester of pregnancy to once or twice daily iron supplementation

Condition or disease Intervention/treatment Phase
Anemia in Pregnancy Drug: Placebo Drug: Ferrous Sulfate Not Applicable

Detailed Description:
Women defined as having iron deficiency anemia based on a low hemoglobin as defined by the American College of Obstetrics and Gynecology and a low serum ferritin, in the absence of hemoglobinopathy, will be randomized to ferrous sulfate 325mg PO daily or PO twice daily.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Once Daily Versus Twice Daily Iron Supplementation to Treat Anemia in Pregnancy: A Prospective, Randomized, Placebo Controlled, Double Blinded, Clinical Trial
Study Start Date : June 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Once Daily Dosing
Randomized to 325mg of ferrous sulfate in the morning and placebo in the evening
Drug: Placebo
Cellulose placebo that will be used in place of a second dose of ferrous sulfate in the subjects randomized to once daily dosing of ferrous sulfate

Drug: Ferrous Sulfate
Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.

Twice Daily Dosing
Randomized to 325mg of ferrous sulfate in the morning and 325mg of ferrous sulfate in the evening
Drug: Ferrous Sulfate
Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.




Primary Outcome Measures :
  1. Hemoglobin [ Time Frame: Change in hemoglobin from baseline to one day postpartum ]
    Maternal Hemoglobin will be measured at baseline, at the time of admission for labor and delivery and on post partum day one

  2. Incidence of gastrointestinal side effects (i.e. constipation, upset stomach) as measured by a validated questionaire [ Time Frame: From enrollment to delivery, which will be an average of 10-12 weeks ]
    Gastrointestinal side effects (i.e. constipation, upset stomach) as measured by a validated questionaire


Secondary Outcome Measures :
  1. Incidence of blood transfusion at delivery [ Time Frame: At delivery ]
    The number of units of blood product transfused during the admission for delivery will be recorded



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton gestation
  • Iron deficiency anemia as defined by a Hgb of less than 11mg/dL in the first and 3rd trimester and 10.5mg/dL in the 2nd trimester and a serum ferritin of less than 15ug/mL.
  • In accordance with American College of Obstetricians and Gynecologists (ACOG) guidelines, the Hgb cutoff will be reduced by 0.8mg/dL in African American women.
  • In accordance with the standard of care, African American women and those with a mean corpuscular volume (MCV) on their routine screening complete blood count (CBC) of less than 70 will require a hemoglobin electrophoresis to exclude hemoglobinopathy prior to enrollment.

Exclusion Criteria:

  • Multiple gestation
  • Maternal hemoglobinopathy or hemochromatosis,
  • Irritable bowel disease or irritable bowel syndrome
  • History of bariatric surgery or extensive bowel surgery
  • Individuals already receiving iron supplementation aside from prenatal vitamins.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839096


Contacts
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Contact: Daniel Jackson 5734996041 jacksondl@health.missouri.edu
Contact: Elizabeth J Mosby, MS 573-817-3275 mosbyej@health.missouri.edu

Locations
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United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia

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Responsible Party: Daniel Lee Jackson, Assistant Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02839096     History of Changes
Other Study ID Numbers: 2004638
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Anemia
Hematologic Diseases