- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05423249
Treatment of Non-Anemic Iron Deficiency in Pregnancy
Treatment of Non-Anemic Iron Deficiency in Pregnancy: a Double-Blind Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All women who fit the inclusion criteria will be approached to be recruited for participation at Stony Brook University Hospital outpatient clinic at less than 20 weeks gestational age. Women who agree to participate in the study will be consented. The study team member will obtain consent from participants and randomize the patient into either the treatment or placebo group based on a 1:1 randomization scheme generated by randomization.com. The study team member will remain blinded, as randomization of subjects will be coordinated by departmental research coordinator, who will not have any interaction with subjects. The treatment group will receive oral ferrous sulfate 325mg (containing 65 mg of elemental iron) daily and a prenatal vitamin, and the placebo group will receive prenatal vitamin and a placebo pill. The prenatal vitamin, which contains iron, will be the same exact formula and will be given to all participants in both control and treatment groups. Only the treatment group will receive the extra iron supplement. The treatment group will also receive vitamin C 500mg daily to assist with iron absorption. Both groups will receive oral docusate sodium (Colace) 100mg twice daily as needed to decrease the risk of constipation.
The randomization will be blinded to the participant, along with the medical provider and study team. Since the Research Pharmacy is able to combine the iron and Vitamin C into one pill, and both groups will receive Colace and prenatal vitamin, the total pill count will not differ from the treatment group and placebo group.
Patients who agree to participate in the study will continue with routine prenatal care and testing, which includes a repeat complete blood count (CBC) in both the second and third trimester, at approximately 24-28 weeks and 34-36 weeks, as is standard of care. In the second and third trimester, a questionnaire will be given to the subject to assess fatigue scores, experience of side effects and severity of side effects. At that time, a study team member will also perform a pill count to assess for compliance.
At time of admission to the hospital for delivery, a repeat ferritin level will be drawn with routine lab work, including a CBC, with no additional risk of blood draw to the patient as this is part of standard of care. The ferritin test will be for research purposes for the study, but will not require an additional blood draw. Clinical anemia will be defined as a hemoglobin level less than or equal to 11 g/dL. While there is no normative data in the literature on ferritin levels in pregnancy, we will define a low ferritin level as <30 mcg/L based on both retrospective pregnancy data and standardized ferritin levels in the non pregnant patient population.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bijal D Parikh, MD
- Phone Number: 908-456-1397
- Email: bijal.parikh@stonybrookmedicine.edu
Study Contact Backup
- Name: Kimberly Herrera, MD
- Phone Number: 631-708-8189
- Email: kimberly.herrera@stonybrookmedicine.edu
Study Locations
-
-
New York
-
Bohemia, New York, United States, 11716
- Recruiting
- University Associates in Obstetrics & Gynecology
-
Contact:
- Joan Kollegger
-
Commack, New York, United States, 11725
- Recruiting
- University Associates in Obstetrics & Gynecology
-
Contact:
- Andrea Pressley, LPN
-
East Setauket, New York, United States, 11733
- Recruiting
- University Associates in Obstetrics & Gynecology
-
Contact:
- Donielle Napoli
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- English speaking
- age 18-55
- less than 20 weeks gestational age
- low ferritin level (<30mcg/L) in the first trimester
- normal hemoglobin level (>11g/dL) in the first trimester
Exclusion Criteria:
- Women with anemia diagnosed in the first trimester (HgB ≤11 g/dL)
- Women with antepartum iron supplementation, except prenatal vitamin, within 3 months
- Women with iron overload or hypersensitivity
- Women with significant vaginal bleeding prior to enrollment
- Women with chronic illness: SLE, hemoglobinopathies, HIV, inflammatory bowel disease, active cancer, prior bariatric surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group
The treatment group will receive oral ferrous sulfate 325mg (containing 65 mg of elemental iron) once daily, an oral prenatal vitamin once daily, oral ascorbic acid 500mg once daily, and oral docusate sodium 100mg twice daily as needed.
|
Oral ferrous sulfate 325 mg once daily, containing 65 mg of elemental iron to treat non-anemic iron deficiency
Oral prenatal vitamin once daily for both groups
Oral docusate sodium 100 mg twice daily as needed, to treat constipation secondary to oral iron supplementation
Oral ascorbic acid 500 mg daily, to improve absorption of oral iron
|
Placebo Comparator: Placebo Group
The placebo group will receive a placebo bill, the same oral prenatal vitamin, and oral docusate sodium 100mg twice daily as needed.
|
Oral prenatal vitamin once daily for both groups
Oral docusate sodium 100 mg twice daily as needed, to treat constipation secondary to oral iron supplementation
Oral placebo pill once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delivery admission hemoglobin
Time Frame: From date of randomization until to 42 weeks
|
hemoglobin value <11 mg/dL
|
From date of randomization until to 42 weeks
|
Third trimester hemoglobin
Time Frame: 28 weeks to 36 weeks
|
Incidence of anemia, hemoglobin value <11 mg/dL, in the third trimester
|
28 weeks to 36 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal anemia
Time Frame: Enrollment to 30 days postpartum
|
Timing of diagnosis
|
Enrollment to 30 days postpartum
|
Incidence of preterm delivery
Time Frame: Enrollment to 30 days postpartum
|
Preterm delivery rate
|
Enrollment to 30 days postpartum
|
Incidence of maternal hemorrhage
Time Frame: Enrollment to 30 days postpartum
|
Postpartum hemorrhage rate
|
Enrollment to 30 days postpartum
|
Incidence of treatment of anemia
Time Frame: Enrollment to 30 days postpartum
|
Need for IV iron or blood transfusion
|
Enrollment to 30 days postpartum
|
Incidence of infection
Time Frame: Enrollment to 30 days postpartum
|
infection rate
|
Enrollment to 30 days postpartum
|
Maternal hospital stay
Time Frame: Enrollment to 30 days postpartum
|
length of hospital stay
|
Enrollment to 30 days postpartum
|
Infant weight
Time Frame: Time of birth to 30 days of life
|
Birth weight Birth weight, NICU admission, perinatal death
|
Time of birth to 30 days of life
|
Incidence of neonatal intensive care unit admission
Time Frame: Time of birth to 30 days of life
|
Rate of NICU admission Birth weight, NICU admission, perinatal death
|
Time of birth to 30 days of life
|
Rate of poor perinatal outcome
Time Frame: Time of birth to 30 days of life
|
Incidence of perinatal death Birth weight, NICU admission, perinatal death
|
Time of birth to 30 days of life
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Hematologic Diseases
- Anemia, Hypochromic
- Anemia
- Iron Metabolism Disorders
- Anemia, Iron-Deficiency
- Iron Deficiencies
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Gastrointestinal Agents
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Antidiarrheals
- Ascorbic Acid
- Bismuth subsalicylate
Other Study ID Numbers
- IRB2022-00121
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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