- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02839096
Once Versus Twice Daily Iron Supplementation in Pregnant Women
April 17, 2019 updated by: Daniel Lee Jackson, University of Missouri-Columbia
Once Daily Versus Twice Daily Iron Supplementation to Treat Anemia in Pregnancy: A Prospective, Randomized, Placebo Controlled, Double Blinded, Clinical Trial
The investigators will randomize women diagnosed with anemia in the mid-trimester of pregnancy to once or twice daily iron supplementation
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
50
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 Contact
- Name: Daniel Jackson
- Phone Number: 5734996041
- Email: jacksondl@health.missouri.edu
Study Contact Backup
- Name: Elizabeth J Mosby, MS
- Phone Number: 573-817-3275
- Email: mosbyej@health.missouri.edu
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65212
- Recruiting
- University of Missouri
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Once Daily Dosing
Randomized to 325mg of ferrous sulfate in the morning and placebo in the evening
|
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
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.
|
Other: Twice Daily Dosing
Randomized to 325mg of ferrous sulfate in the morning and 325mg of ferrous sulfate in the evening
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change in hemoglobin from baseline to one day postpartum
|
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
|
From enrollment to delivery, which will be an average of 10-12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
June 1, 2016
Primary Completion (Anticipated)
June 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
June 9, 2016
First Submitted That Met QC Criteria
July 19, 2016
First Posted (Estimate)
July 20, 2016
Study Record Updates
Last Update Posted (Actual)
April 18, 2019
Last Update Submitted That Met QC Criteria
April 17, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004638
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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