Pregnancy RelatedPhase 4NCT04594070
Daily Versus Alternate Day Iron Supplementation for the Treatment of Iron Deficiency Anemia in Pregnancy
A Phase 4 study testing Ferrous sulfate in people with Pregnancy Related and Iron Deficiency Anemia of Pregnancy, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The target population for our study is pregnant women in the first or second trimester with a diagnosis of iron deficiency anemia. If a subject is eligible, written consent will be obtained by person to person contact. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy Related, Iron Deficiency Anemia of Pregnancy
- What is being tested?
- Ferrous sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2020to 12 Jan 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Hemoglobin less than 11 g/dl in the first trimester or less than 10.5 g/dl in the second trimester
- Microcytic anemia
- Singleton gestation in the first or second trimester
Who cannot join
- Malabsorptive disorder or history of restrictive or malabsorptive gastric surgery
- Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic, sickle cell, etc.)
- History of cardiopulmonary disease
- Severe anemia requiring parental infusion or transfusion of blood products
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: A Randomized Trial of Intermittent Oral Iron Supplementation vs. Daily Oral Iron Supplementation for the Treatment of Anemia in Pregnancy
The target population for our study is pregnant women in the first or second trimester with a diagnosis of iron deficiency anemia. If a subject is eligible, written consent will be obtained by person to person contact. Eligible participants will be randomized to receive either daily oral iron supplementation or every other day oral iron supplementation.
Read the detailed description
Eligible pregnant women in the first or second trimester who carry a diagnosis of iron deficiency anemia as defined by the American College of Obstetrics and Gynecology will be approached, consented, and randomized to receive either daily oral ferrous sulfate (325mg) supplementation or every other day oral ferrous sulfate (650mg). Participants will undergo a phone survey 2-4 weeks after starting the study to assess for side effects. Participants will continue routine care and surveillance of iron deficiency in pregnancy until the end of pregnancy.
- Being tested
- Ferrous sulfate
- Keywords
- Pregnancy, Iron deficiency, Anemia, Iron supplementation
- Medical subject headings
- Iron Deficiencies, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous sulfateDrug
Iron supplementation
| Study group | Role | What they receive |
|---|---|---|
| Daily iron supplementation | Active comparator | Oral ferrous sulfate, 325 mg, take once daily Receives: Drug: Ferrous sulfate |
| Alternate day iron supplementation | Experimental | Oral ferrous sulfated, 650mg, taken once daily every other day Receives: Drug: Ferrous sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Hemoglobin Levels From Enrollment to End of Study
Hemoglobin levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy
Measured: Baseline and again 8-9 months later (third trimester of pregnancy)
Change in Hematocrit in the Third Trimester After Treatment
Hematocrit levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy
Measured: Baseline and again 8-9 months later (third trimester of pregnancy)
Secondary outcomes (14)
Gastrointestinal Side Effects After 2-4 Weeks of Treatment
Gastrointestinal side effects with treatment will be assessed by telephone survey using a validated questionnaire.
Measured: 2-4 weeks after enrollment
Complete Blood Count in the Third Trimester
Complete blood count indices will be assessed by blood draw upon enrollment and approximately monthly until delivery
Measured: 8-9 months after enrollment (third trimester of pregnancy)
Serum Ferritin at Time of Enrollment
Serum ferritin will assessed by blood draw at time of enrollment.
Measured: Baseline only at time of enrollment
Total Iron Binding Capacity at Time of Enrollment
Total iron binding capacity will assessed by blood draw at time of enrollment.
Measured: Baseline only at time of enrollment
Transferrin at Time of Enrollment
Transferrin levels will assessed by blood draw at time of enrollment.
Measured: Baseline only at time of enrollment
Number of Participants Who Receive Intravenous (IV) Iron Supplementation
By chart review, we will determine if the subject received parental (IV) iron supplementation as part of the treatment for iron deficiency anemia
Measured: At completion of study, on average after 9 months
Number of Participants Who Receive a Blood Transfusion
By chart review, we will determine if the subject received a blood transfusion as part of the treatment for iron deficiency anemia
Measured: At completion of study, on average after 9 months
Postpartum Hemoglobin
Hemoglobin levels after delivery will be recorded (if obtained as part of regular postpartum care)
Measured: At completion of study, on average after 9 months
Postpartum Hematocrit
Hematocrit levels after delivery will be recorded (if obtained as part of regular postpartum care)
Measured: At completion of study, on average after 9 months
Neonatal Weight at Delivery
The weight of the baby (in grams) will be determined by chart review at the end of enrollment
Measured: At completion of study, on average after 9 months
Level of Neonatal Bilirubin at Birth
Neonatal hyperbilirubinemia will be reviewed and recorded by chart review
Measured: At completion of study, on average after 9 months
Neonatal Apgar Scores
Neonatal Apgar scores will be reviewed and recorded by chart review. The Apgar score is a method used to describe a newborn's status at birth and response to resuscitation. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. The range of scores is 0 to 10. Higher scores indicate reassuring newborn status.
Measured: At completion of study, on average after 9 months
Number of Newborns Who Are Admitted to the Neonatal Intensive Care Unit (NICU).
The need for Neonatal Intensive Care Unit (NICU) Admission, will be assessed
Measured: At completion of study, on average after 9 months
Weight Class at Time of Enrollment
At time of enrollment the weight of the subject will be assessed and assigned a weight class using the World Health Organization weight classification
Measured: Baseline only at time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start27 Oct 2020
- Primary completion12 Jan 2024
- Study completion12 Jan 2024
Why it stopped: Unable to recruit enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melody Safarzadeh, MD, MS, Principal investigator, UTMB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594070
- Sponsor's protocol ID
- 20-0068
- Status last verified
- Jun 2024
- First submitted
- 30 Sep 2020
- Last updated
- 24 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Intermittent Oral Iron Supplementation vs. Daily Oral Iron Supplementation for the Treatment of Anemia in Pregnancy
- ClinicalTrials.gov ID
- NCT04594070
- Acronym / sponsor ID
- 20-0068
- Keywords
- Pregnancy, Iron deficiency, Anemia, Iron supplementation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit enough participants
- Enrolment
- 14 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Posted 24 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The target population for our study is pregnant women in the first or second trimester with a diagnosis of iron deficiency anemia. If a subject is eligible, written consent will be obtained by person to person contact. Eligible participants will be randomized to receive either daily oral iron supplementation or every other day oral iron supplementation.
Detailed description
Eligible pregnant women in the first or second trimester who carry a diagnosis of iron deficiency anemia as defined by the American College of Obstetrics and Gynecology will be approached, consented, and randomized to receive either daily oral ferrous sulfate (325mg) supplementation or every other day oral ferrous sulfate (650mg). Participants will undergo a phone survey 2-4 weeks after starting the study to assess for side effects. Participants will continue routine care and surveillance of iron deficiency in pregnancy until the end of pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily iron supplementation | Active comparator | Drug: Ferrous sulfateOral ferrous sulfate, 325 mg, take once daily |
| Alternate day iron supplementation | Experimental | Drug: Ferrous sulfateOral ferrous sulfated, 650mg, taken once daily every other day |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Hemoglobin less than 11 g/dl in the first trimester or less than 10.5 g/dl in the second trimester
- Microcytic anemia
- Singleton gestation in the first or second trimester
Key exclusion criteria (4 listed)
- Malabsorptive disorder or history of restrictive or malabsorptive gastric surgery
- Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic, sickle cell, etc.)
- History of cardiopulmonary disease
- Severe anemia requiring parental infusion or transfusion of blood products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous sulfateIron supplementation | Drug | Alternate day iron supplementation, Daily iron supplementation |
Primary outcome
Difference in Hemoglobin Levels From Enrollment to End of Study
Time frame: Baseline and again 8-9 months later (third trimester of pregnancy)
Hemoglobin levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy
Change in Hematocrit in the Third Trimester After Treatment
Time frame: Baseline and again 8-9 months later (third trimester of pregnancy)
Hematocrit levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy
14 secondary outcomes
Gastrointestinal Side Effects After 2-4 Weeks of Treatment
Time frame: 2-4 weeks after enrollment
Complete Blood Count in the Third Trimester
Time frame: 8-9 months after enrollment (third trimester of pregnancy)
Serum Ferritin at Time of Enrollment
Time frame: Baseline only at time of enrollment
Total Iron Binding Capacity at Time of Enrollment
Time frame: Baseline only at time of enrollment
Transferrin at Time of Enrollment
Time frame: Baseline only at time of enrollment
Number of Participants Who Receive Intravenous (IV) Iron Supplementation
Time frame: At completion of study, on average after 9 months
Number of Participants Who Receive a Blood Transfusion
Time frame: At completion of study, on average after 9 months
Postpartum Hemoglobin
Time frame: At completion of study, on average after 9 months
Postpartum Hematocrit
Time frame: At completion of study, on average after 9 months
Neonatal Weight at Delivery
Time frame: At completion of study, on average after 9 months
Level of Neonatal Bilirubin at Birth
Time frame: At completion of study, on average after 9 months
Neonatal Apgar Scores
Time frame: At completion of study, on average after 9 months
Number of Newborns Who Are Admitted to the Neonatal Intensive Care Unit (NICU).
Time frame: At completion of study, on average after 9 months
Weight Class at Time of Enrollment
Time frame: Baseline only at time of enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melody Safarzadeh, MD, MS principal investigator
UTMB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferrous sulfate in people with Pregnancy Related and Iron Deficiency Anemia of Pregnancy, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Hemoglobin Levels From Enrollment to End of Study (time frame: Baseline and again 8-9 months later (third trimester of pregnancy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.